Drug Approvals          Showing: Last 12 Months |All Drug Approvals

TUESDAY, Jan. 31 (HealthDay News) -- Kalydeco (ivacaftor) has been approved by the U.S. Food and Drug Administration to treat the root cause of a rare form of the inherited disease cystic fibrosis.

CF causes a deadly buildup of thick mucus in the lungs and other organs. Kalydeco was sanctioned to treat people 6 and older whose CF is caused by a mutation of the G551D gene, which oversees the distribution of water throughout the body, the FDA said in a news release.

CF affects about 30,000 people in the United States, and is the most common fatal genetic disease among whites, the agency said. Some 4 percent of cases, or approximately 1200 people, are thought to have the G551D mutation.

Kalydeco was given priority six-month review and was given orphan drug status, since the targeted form of CF affects fewer than 200,000 people in the United States, the FDA said.

The twice-daily pill was approved based on clinical studies involving 213 people with the G551D mutation. The most common side effects included upper respiratory tract infection, headache, stomach ache, diarrhea and dizziness.

Kalydeco is not effective in people with the most common genetic cause of CF, the FDA stressed. The drug is produced by Vertex Pharmaceuticals, based in Cambridge, Mass.

More information

To learn more about cystic fibrosis, visit Medline Plus.

MONDAY, January 30 (HealthDay News) -- Erivedge (vismodegib) has been approved by the U.S. Food and Drug Administration to treat the most common form of skin cancer, basal cell carcinoma, the agency said Monday.

The drug was approved for people for whom surgery or radiation aren't options, and for people with basal cell that has spread to other parts of the body, according to an FDA news release.

Basal cell usually is a slow-growing, painless type of cancer that begins in the top layer of skin, often on areas most exposed to the sun.

Erivedge was evaluated in clinical studies involving 96 people with basal cell carcinoma. The most common side effects included muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted taste, loss of appetite and constipation.

The drug was approved with an FDA's label warning that pregnant women who take Erivedge could have babies at greater risk of severe birth defects or death. "Pregnancy status must be verified prior to the start of Erivedge treatment," the agency release advised.

Erivedge is marketed by Genentech, based in San Francisco, Calif.

More information

Medline Plus has more about basal cell carcinoma.

FRIDAY, Jan. 27 (HealthDay News) -- Bydureon (exenatide extended release), Amylin Pharmaceuticals' long-acting version of the diabetes drug Byetta, has been approved by the U.S. Food and Drug Administration.

The once-weekly injection will include a label warning that the drug caused certain thyroid tumors in rats, the Dow Jones news service reported. It's not known whether the drug causes such tumors in people, the label warning says. But the drug shouldn't be used by people with a family history of medullary thyroid carcinoma (a form of cancer), the warning continues.

Twice in 2010, the FDA declined approval of Bydureon, requesting additional studies and clinical information, Dow Jones reported.

Bydureon is a "glucagon-like peptide-1 (GLP-1) receptor," a class of medications that helps the body produce more insulin, which helps regulate blood sugar.

Amylin is based in San Diego, Calif.

More information

For more about type 2 diabetes, visit MedlinePlus.

FRIDAY, Jan. 27 (HealthDay News) -- Inlyta (axitinib) has been approved by the U.S. Food and Drug Administration to treat advanced renal cell carcinoma in people who haven't responded to another drug.

Renal cell carcinoma is a form of kidney cancer that begins in tissue that lines the kidney's small tubes. Inlyta blocks proteins that help fuel tumor growth in this area, the FDA said in a news release.

Six medications had been sanctioned previously for advanced kidney cancer, the agency said.

In a study of 723 people with the advanced form of kidney cancer, the most common side effects of Inlyta included diarrhea, high blood pressure, fatigue, loss of appetite, nausea, loss of voice, weight loss, weakness and constipation.

Among some patients, Inlyta also caused significant bleeding, which in some cases proved fatal. The FDA also warned that people with high blood pressure should make sure the problem is well controlled before taking the twice-daily drug.

People with untreated brain tumors or gastrointestinal bleeding should not take Inlyta, the FDA said.

The drug is marketed by Pfizer.

More information

Medline Plus has more about renal cell carcinoma.

FRIDAY, Jan. 20 (HealthDay News) -- The first test to help determine the risk of a rare brain infection among users of the drug Tysabri has been approved by the U.S. Food and Drug Administration.

Tysabri (natalizumab) is commonly prescribed to treat multiple sclerosis or Crohn's disease. A relatively small number of users have developed a rare brain infection called progressive multifocal leukoencephalopathy (PML). The newly approved Stratify JCV Antibody ELISA test, combined with other clinical data, can help doctors evaluate the risk of developing PML among people who take Tysabri to treat MS or Crohn's, the FDA said in a news release.

There is "no treatment, prevention or cure for PML, and no certain way to predict who will develop it," the agency stressed. But it said risk factors for PML include the presence of antibodies for the John Cunningham virus, a normally harmless germ except among people with weakened or medically suppressed immune systems.

Other risk factors for developing PML, the FDA said, include taking Tysabri for at least two years, or taking other drugs that suppress the immune system.

The risk for developing PML, believed to be about 11 in 1,000, is greatest among people with all three risk factors, the agency said.

The newly approved test should not be used on its own to measure a person's risk of developing PML, nor should it be used to diagnose the rare infection, the FDA said.

The new test is manufactured by Focus Diagnostics, based in Cypress, Calif. Tysabri is co-marketed by Biogen Idec and Elan Corp.

More information

The FDA has more about Tysabri.

WEDNESDAY, Jan. 18 (HealthDay News) -- Voraxaze (glucarpidase) has been approved by the U.S. Food and Drug Administration to treat high blood levels of methotrexate, a common chemotherapy drug.

While methotrexate is normally removed from the blood by the kidneys, people who are prescribed high levels of methotrexate may develop kidney failure, leading to a buildup of the drug in the bloodstream.

Voraxaze is an enzyme that breaks down methotrexate into a form that is more easily eliminated from the body, the FDA said in a news release.

A toxic buildup of methotrexate can lead to kidney and liver damage, mouth sores, intestinal damage, skin rash and sometimes death, the agency said.

Voraxaze was evaluated in a clinical trial of 22 people. Ten of the 22 participants saw blood methotrexate levels fall below a critical level within 15 minutes. Among all participants, Voraxaze eliminated 95 percent of methotrexate, the FDA said.

The most common side effects of Voraxaze included low blood pressure, headache, nausea, vomiting and flushing.

Voraxaze is marketed by BTG International of West Conshohocken, Penn.

More information

Medline Plus has more about methotrexate.

MONDAY, Jan. 16 (HealthDay News) -- The U.S. Food and Drug Administration has expanded approval of an endovascular graft to include ruptures of the aorta, the body's largest artery.

The Gore Tag Thoracic Endoprosthesis was first sanctioned in 2005 to treat aortic bulges called aneurysms, the agency said in a news release. Use of the graft to treat aortic tears will spare patients more invasive open chest surgery.

The graft, produced by Flagstaff, Arizona-based W.L. Gore and Associates, contains a metal mesh frame surrounded by a fabric tube. Implantation is done via a catheter inserted into a leg artery.

Approval for the new use was granted based on clinical studies involving 51 people with aortic tears. Gore will follow patients implanted with the device for five years, the FDA said.

More information

Medline Plus has more about tears of the aorta.

TUESDAY, Jan. 3 (HealthDay News) -- The Prevnar 13 bacterial pneumonia vaccine has been approved for people aged 50 and older, the U.S. Food and Drug Administration said.

The vaccine targets pneumonia and other diseases caused by the bacterium Streptococcus pneumoniae. The shot, targeting 13 serotypes of the bacterium, has already been approved for children aged 6 weeks through 5 years to prevent invasive disease and certain ear infections, the agency said in a news release.

In clinical testing for the expanded use of the vaccine, people 50 and older were either given Prevnar 13 or another licensed pneumococcal vaccine, Pneumovax 23. The studies found Prevnar 13 induced levels of immune system antibodies that were either comparable or higher than those of Pneumovax 23, the FDA said.

Common side effects of Prevnar 13 included injection-site swelling, redness and pain, fatigue, headache, chills, muscle pain and joint pain.

An additional study in 85,000 people aged 65 or older is ongoing, the agency said.

Prevnar 13 is produced by Wyeth Pharmaceuticals, based in Collegeville, Penn.

More information

The U.S. Centers for Disease Control and Prevention has more about pneumococcal disease.

WEDNESDAY, Dec. 21 (HealthDay News) -- Approval for the HIV drug Isentress (raltegravir) has been expanded to include children and adolescents ages 2-18, the U.S. Food and Drug Administration said Wednesday.

The drug is an integrase strand transfer inhibitor that helps slow the spread of the AIDS-causing virus throughout the body, the agency said in a news release. It was first approved for adults in October 2007.

The twice-daily pill is available in a chewable form for people aged 2 to 11, and in non-chewable form. Clinical testing of the drug among 96 children and teens with HIV-1 infection showed 53 percent of patients had undetectable blood HIV levels after 24 weeks, the FDA said.

The most common reported side effects of Isentress included trouble sleeping and headache.

The drug does not cure HIV infection, and patients must take Isentress continually to ensure ongoing reduction in HIV-related illness, the FDA stressed.

The drug is produced by Merck & Co., based in Whitehouse Station, N.J.

More information

The U.S. Department of Health and Human Services has more about HIV/AIDS.

TUESDAY, Dec. 20 (HealthDay News) -- Edarbyclor (azilsartan medoxomil and chlorthalidone) has been approved by the U.S. Food and Drug Administration to treat high blood pressure in adults, maker Takeda Pharmaceutical Co. Ltd. said Tuesday in a news release.

The drug combines Edarbi, an angiotensin II receptor blocker, with the diuretic chlorthalidone. The former blocks the actions of a natural hormone, allowing blood vessels to stay relaxed and open. Diuretics increase the flow of urine from the body, which helps lower blood pressure.

In clinical testing, the combination drug lowered blood pressure "significantly more" than either drug taken alone, Takeda said. The most common adverse reactions included dizziness and fatigue.

High blood pressure affects about 75 million Americans, or nearly one in three adults, the Japanese drug maker said. This includes more than half of people aged 60 and older.

More information

The U.S. National Heart Lung and Blood Institute has more about lowering blood pressure.

FRIDAY, Dec. 16 (HealthDay News) -- A cardiac assist device that's designed to keep a child with heart failure alive until doctors can find a donor heart has been approved by the U.S. Food and Drug Administration.

The blood-pumping Excor Pediatric System is produced in different sizes to fit newborns to teens. While heart failure is rarer in children than adults, there are also fewer pediatric-size heart donors, the FDA said in a news release.

These and other factors make the average waiting time for an infant-sized heart 119 days, the FDA said, so as many as 23 percent of infants die while waiting for a heart transplant. As many as 17 percent of children die under the same circumstances.

Excor has been designated a humanitarian use device by the FDA, since it affects fewer than 4,000 people in the United States each year. The makers of such devices must show that their use outweighs the devices' risk of illness or injury, the agency said.

The Excor system is produced by the German firm Berlin Heart.

More information

Medline Plus has more about heart failure.

THURSDAY, Dec. 1 (HealthDay News) -- The first generic version of the cholesterol-lowering statin Lipitor (atorvastatin calcium) has been approved by the U.S. Food and Drug Administration.

Drug maker Ranbaxy Laboratories, based in India, has gained approval to produce the tablets in 10 milligram (mg), 20 mg, 40 mg and 80 mg strengths, the FDA said in a news release. The agency stressed that makers of generic drugs are required to pass the same production- and packaging-quality standards as producers of brand-name drugs.

People with above-normal levels of low-density lipoprotein (LDL, the so-called "bad" cholesterol), are at greater risk of heart attack and stroke when LDL levels build up in the arteries and inhibit blood flow. Lipitor blocks an enzyme in the liver, helping to lower levels of LDL and another form of blood cholesterol, triglycerides.

In clinical trials for the brand-name Lipitor, produced by Pfizer, the most common side effects included nasal inflammation, joint pain, diarrhea and urinary tract infection.

More information

To learn more about this approval, visit the FDA.

FRIDAY, Nov. 18 (HealthDay News) -- Erwinaze (asparaginase Erwinia chrysanthemi) has been approved by the U.S. Food and Drug Administration to treat Acute Lymphoblastic Leukemia (ALL) among people who have developed an allergy to more standard treatments.

In this type of cancer, bone marrow produces too many infection-fighting white blood cells called lymphocytes. Typically, treatments include asparaginase and pegaspargase chemotherapy drugs. But some patients develop allergies to these medications.

Newly approved Erwinaze, injected into a muscle three times weekly, breaks down a protein building block that helps overabundant white blood cells (leukemia cells) grow. Without this protein, the leukemia cells die, the FDA said in a news release.

The safety and effectiveness of Erwinaze were evaluated in clinical studies involving 58 people. Additional safety data was harvested from a separate trial involving 843 patients, the FDA said. Observed side effects of Erwinaze included severe allergic reactions, pancreatic inflammation, high liver enzymes, abnormal bleeding or clotting, nausea and high blood sugar.

Erwinaze has been designated an orphan drug, since ALL affects fewer than 200,000 people in the United States, the FDA said.

The drug is produced by EUSA Pharma Inc., based in Langhorne, Pa.

More information

Medline Plus has more about this form of cancer.

WEDNESDAY, Nov. 16 (HealthDay News) -- Jakafi (ruxolitinib) has been approved by the U.S. Food and Drug Administration as the first drug to treat myelofibrosis, a rare disease of the bone marrow, the agency said Wednesday.

In cases of myelofibrosis, healthy bone marrow is replaced by scar tissue, causing blood cells to be made in the liver, spleen and other organs. Symptoms often include an enlarged spleen, anemia, a decrease in white blood cells and platelets, fatigue, abdominal discomfort, pain under the ribs, muscle and bone pain, itching and night sweats, the FDA said in a news release.

Jakafi inhibits the actions of two enzymes that are involved in regulating blood, the agency said. The drug was evaluated in clinical studies involving 528 people, all of whom had an enlarged spleen.

Observed side effects included low blood platelet levels, anemia, fatigue, diarrhea, shortness of breath, headache, dizziness, nausea and confusion.

Jakafi was approved as an orphan drug, since myelofibrosis affects fewer than 200,000 people in the United States, the FDA said.

The drug is produced by Incyte Corp., based in Wilmington, Del.

More information

The FDA has more about this approval.

FRIDAY, Nov. 11 (HealthDay News) -- The first product in the United States that uses human umbilical cord stem cells to treat disorders of the hematopoietic (blood-forming) system has been approved by the Food and Drug Administration.

Hemacord was approved for treating conditions including certain blood cancers and disorders of the immune system, the agency said in a news release.

The product contains blood-forming progenitor cells that when infused into patients, travel to the bone marrow, then divide and mature. Once the mature cells move into the bloodstream, they can help restore typical blood-cell function, boosting the immune system, the FDA said.

However, the product's label warns of potential reactions including fatal cases of Graft Versus Host Disease, engraftment syndrome, graft failure or infusion reactions, the agency stressed.

Hemacord was created by the New York City-based New York Blood Center.

More information

To learn more about the use of hematopoietic stem cells, visit the U.S. National Institutes of Health.

MONDAY, Nov. 7 (HealthDay News) -- U.S. Food and Drug Administration approval of Erbitux (cetuximab) has been expanded to include late-stage (metastatic) head and neck cancer, the agency announced Monday.

The drug was first approved in 2004 to treat colon cancer, and was later sanctioned to treat non-metastatic cases of head and neck cancer.

Clinical testing for the newly approved use involved 442 people with metastatic or recurring head and neck cancer. People who received Erbitux and chemotherapy lived an average of 10.1 months, compared with 7.4 months among those who received chemotherapy alone.

Head and neck cancer accounts for up to 5 percent of all cancer cases in the United States, and is most common in men and in people older than age 50, the FDA said, citing statistics from the U.S. National Cancer Institute.

The most common side effects reported for Erbitux include rash, itching, nail changes, headache, diarrhea, and respiratory, skin and mouth infections. People who take Erbitux should limit exposure to the sun, the FDA warned.

The drug is marketed by Bristol-Myers Squibb, based in New York City, and Indianapolis-based Eli Lilly & Co.

More information

The National Cancer Institute has more about head and neck cancer.

FRIDAY, Nov. 4 (HealthDay News) -- The anti-clotting drug Xarelto (rivaroxaban) has been approved by the U.S. Food and Drug Administration to prevent stroke in people with atrial fibrillation, a common form of irregular heartbeat.

More than 2 million Americans have atrial fibrillation, in which the heart's two upper chambers beat irregularly, the FDA said in a news release. The condition can lead to the formation of a blood clot, which can travel to the brain and cause a stroke. The new drug was approved for cases in which the atrial fibrillation is unrelated to the performance of the heart's valves.

Xarelto's safety and effectiveness were compared to those of another anti-clotting drug, warfarin, in clinical studies involving some 14,000 patients. Xerelto was deemed similar to warfarin in its ability to prevent stroke, the FDA said.

As with other anti-clotting drugs, Xarelto has the ability to cause bleeding, which in rare cases can lead to death, the agency said.

The drug's label has the FDA's most urgent "black box" warning that the drug should never be discontinued before the patient discusses the situation with a physician. Stopping the drug could increase the risk of stroke, the FDA warned.

In July, Xarelto received initial approval to reduce a user's risk of blood clots, deep vein thrombosis and pulmonary embolism after replacement surgery of the knee or hip.

The drug is marketed by Janssen Pharmaceuticals, based in Titusville, N.J.

More information

To learn more about atrial fibrillation, visit the U.S. National Heart Lung and Blood Institute.

THURSDAY, Nov. 3 (HealthDay News) -- The first artificial heart valve that can replace a diseased aortic valve without requiring open-heart surgery has been approved by the U.S. Food and Drug Administration.

A patient's aortic valve can be damaged by stenosis, a narrowing of the valve caused by the buildup of calcium deposits. The heart must then work harder to pump blood through the diseased valve, which could lead to symptoms including fainting, chest pain, heart failure, irregular heartbeat or cardiac arrest. More than half of the people with these symptoms die within two years, the FDA said in a news release.

Traditionally, replacement of this valve has required open-heart surgery. But the newly approved Sapien Transcatheter Heart Valve (THV) allows doctors to implant it using a tube-shaped device called a delivery catheter, via a small incision in the leg. The catheter is slightly wider than a pencil.

This can benefit patients for whom open-heart surgery is too risky, the FDA said.

The agency said patients in whom the new device was implanted had 2 1/2 times more strokes, and eight times as many vascular or bleeding complications than those who didn't get the implant. At the same time, clinical testing found that 69 percent of patients who received the new device were alive a year after the implant, compared with 50 percent who were treated by a different method.

Maker Edwards Lifescience will continue to monitor patients who receive the implant, the agency said. The device is not recommended for people who can be treated with open-heart surgery.

Edwards Lifescience is based in Irvine, Calif.

More information

The U.S. National Heart Lung and Blood Institute has more about heart valve disease.

WEDNESDAY, Nov. 2 (HealthDay News) -- A device that helps repair abdominal aneurysms in people with small arteries has been approved by the U.S. Food and Drug Administration.

An aneurysm is a bulge in a weak part of an artery. If the bulge bursts, the patient is at risk of dying from internal bleeding. The aorta is the body's largest artery, carrying oxygenated blood from the heart, through the abdomen, and then branching off into the head, neck, arms and legs.

A bulge that forms in this artery as it passes through the abdomen is called an abdominal aortic aneurysm. Treatment often involves a hollow metal tube called a stent, which can help redirect blood flow away from the aneurysm.

In some people, however, the blood vessels are too small to accommodate the stent and additional hardware -- collectively known as an endograft. The new Ovation Abdominal Stent Graft System uses hardware that's narrower in diameter than is typically used, the FDA said in a news release.

Adverse reactions to the newly approved device were similar to those of larger endograft devices, affecting the blood, lymphatic, cardiac, gastrointestinal and pulmonary systems.

More information

The FDA has more about this approval.

WEDNESDAY, Nov. 2 (HealthDay News) -- MelaFind -- a device that creates digital images of suspicious skin growths and compares them to a database of thousands of scans to analyze for signs of melanoma skin cancer -- has been approved by the U.S. Food and Drug Administration.

The non-invasive diagnostic can help doctors decide whether to biopsy skin growths in their early stages, when skin cancer is nearly 100 percent curable, device maker Mela Sciences said in a news release.

Melanoma, if not caught in its earliest stages, is the deadliest form of skin cancer. It accounts for about 75 percent of skin cancer deaths, the company said.

While the new technology can recommend to doctors whether to perform a biopsy, it is not intended to confirm a clinical diagnosis of melanoma, Mela said.

The company is based in Irvington, N.Y.

More information

The U.S. National Cancer Institute has more about melanoma.

MONDAY, Oct. 31 (HealthDay News) -- Exparel (bupivacaine liposome injectable suspension) has been approved by the U.S. Food and Drug Administration to treat post-surgical pain, maker Pacira Pharmaceuticals said Monday.

The product combines the long-acting anesthetic bupivacaine with Pacira's DepoFoam delivery technology. A single dose can provide relief for up to 72 hours and reduce the need for opioid painkillers, the drug maker said in a news release.

Exparel was evaluated in 21 clinical studies, including more than 1,300 participants. The most common side effects reported included nausea, constipation and vomiting, Pacira said.

The company is based in Parsippany, N.J.

More information

To learn more about pain, visit Medline Plus.

MONDAY, Oct. 24 (HealthDay News) -- The first generic versions of Zyprexa (olanzapine) have been approved by the U.S. Food and Drug Administration to treat schizophrenia or bipolar disorder, the agency said Monday.

Olanzapine has a boxed label warning that the drug can cause death among elderly people who have psychosis due to confusion and memory loss, the FDA said in a news release. Other serious adverse reactions could include high blood sugar, high cholesterol or triglycerides, and weight gain.

Schizophrenia is a brain disorder that affects about 1 percent of Americans, with symptoms including hearing voices, paranoia, being suspicious and withdrawing from everyday life. Bipolar disorder, also known as manic-depressive illness, includes symptoms such as unusual changes in mood, energy and ability to perform daily tasks.

The agency said any generic drugs it approves are clinically equivalent to the brand-name versions in quality, strength, purity and stability.

Approval to produce generic versions of olanzapine were given to: Dr. Reddy's Laboratories Ltd., Teva Pharmaceuticals USA, Apotex Inc. and Par Phamaceuticals Inc.

More information

The FDA has more about Zyprexa.

MONDAY, Oct. 24 (HealthDay News) -- Onfi (clobazam) tablets have been approved by the U.S. Food and Drug Administration as an add-on treatment for severe seizures associated with Lennox-Gastaut syndrome in people 2 years and older, the agency said Monday in a news release.

Lennox-Gastaut typically begins before age 4, and may be caused by factors including brain malformation, severe head injury, central nervous system infection and a number of genetic conditions, the FDA said.

Most affected children have impaired intellect, developmental delays and behavioral problems, the agency added.

Since the condition affects fewer than 200,000 people in the United States, the medication was given the agency's so-called "orphan drug" status. Common adverse reactions observed during clinical testing included sedation, fever, drooling, constipation, cough, urinary tract infection, insomnia, aggression, irritability, vomiting, swallowing problems, bronchitis and pneumonia, the FDA said.

As with other antiepileptic drugs, Onfi may increase the risk of suicidal thoughts and behaviors in a small number of users, the agency warned. All users should be carefully monitored for these symptoms, the FDA said.

The drug may also cause sedation, so older users shouldn't drive or use heavy machinery. Onfi has been categorized as a Schedule IV drug under the Controlled Substances Act, the FDA said.

The drug is manufactured by Catalent Pharma Solutions, based in Winchester, Ky.

More information

Visit the U.S. National Institute of Neurological Disorders and Stroke to learn more about Lennox-Gastaut syndrome.

FRIDAY, Oct. 14 (HealthDay News) -- Ferriprox (deferiprone) has been approved by the U.S. Food and Drug Administration to treat excess blood iron among people who require frequent transfusions.

People with the genetic blood disorder thalessemia have an insufficient supply of hemoglobin, the protein that helps deliver oxygenated blood throughout the body. They often need frequent blood transfusions, which may lead to a buildup of iron in the blood (iron overload). People with thalessemia also are at greater-than-average risk of developing liver disease, diabetes, arthritis, heart failure or an abnormal heart rhythm, the FDA said in a news release.

Ferriprox has been approved for use in cases where other methods to remove excess iron are insufficient, the agency said.

In clinical testing of the drug, the most common side effects noted were nausea, vomiting, abdominal and joint pain, discolored urine, a potentially deadly decrease in infection-fighting white blood cells, and an increase in a liver enzyme that may indicate tissue or liver damage.

As a condition of approval, the Toronto-based drug maker ApoPharma must study the use of Ferriprox among people with iron overload who also have sickle cell disease, the FDA said.

More information

The U.S. Centers for Disease Control and Prevention has more about iron overload.

FRIDAY, Oct. 7 (HealthDay News) -- Juvisync (sitagliptin and simvastatin) has been approved by the U.S. Food and Drug Administration for people with type 2 diabetes who also have high cholesterol.

The single pill combines two previously approved drugs, Januvia and Zocor. Some 20 million people in the United States have type 2 diabetes, and many also have high cholesterol. The conditions, especially if left untreated, can increase a person's risk of heart disease, stroke, kidney disease and blindness, the agency said in a news release.

The FDA noted that recent studies have suggested that statins, of which simvastatin is one, may prompt a rise in blood sugar levels among people with type 2 diabetes. But "this risk appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes," the agency said, noting it would require Juvisync's label to alert doctors to this possibility.

The FDA said it also would require Merck & Co. to conduct post-approval studies that compare sitagliptin alone with the combination drug in lowering blood glucose levels.

The most common side effects of Juvisync are upper respiratory infection, stuffy nose, sore throat, headache, muscle and stomach pain, constipation and nausea, the agency said.

More information

The American Diabetes Association has more about people with diabetes and high cholesterol.

FRIDAY, Oct. 7 (HealthDay News) -- The erectile dysfunction drug Cialis (tadalafil) has received new approval from the U.S. Food and Drug Administration to treat benign prostatic hyperplasia (BPH), the medical term for an enlarged prostate.

Symptoms of BPH frequently include difficulty urinating, a sudden urge to urinate, and an increase in having to urinate, notably at night.

The drug was evaluated among men with BPH in three trials. Those who took 5 milligrams of Cialis once daily showed significant reduction in symptoms of BPH, the FDA said in a news release. The third trial involved men with BPH who also had been diagnosed with erectile dysfunction.

Men who take a class of drugs called nitrates, including nitroglycerin, shouldn't take Cialis in tandem, since the combination could lead to an unsafe drop in blood pressure, the FDA said. The agency made a similar warning about taking Cialis along with alpha blocker drugs, which typically are prescribed to treat high blood pressure or anxiety.

Eight other drugs have been approved to treat symptoms of BPH: Proscar (finasteride), Avodart (dutasteride), Jalyn (dutasteride and tamsulosin), Hytrin (terazosin), Cardura (doxazosin), Flomax (tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).

Cialis is produced by Indianapolis-based Eli Lilly and Co.

More information

The U.S. National Library of Medicine has more about this drug.

TUESDAY, Oct. 4 (HealthDay News) -- LeGoo, a gel to stem blood flow temporarily during surgery that requires joining blood vessels, has been approved by the U.S. Food and Drug Administration.

The product allows surgeons to avoid use of clamps or elastic loops and clearly see where to stitch two vessels together, the agency said in a news release. Injected into a vessel, the gel hardens into a plug that forms to the shape of the vessel, preventing blood flow for up to 15 minutes.

The plug is designed to dissolve on its own, but the process can be sped up if the surgeon applies a cold pack or cold saline to the area, the FDA said.

LeGoo is approved for vessels 4 millimeters or less in diameter, and shouldn't be used on vessels that deliver blood to the brain, the agency warned.

The product is manufactured by PluroMed Inc., based in Woburn, Mass.

More information

To learn more about this approval, visit the FDA.

WEDNESDAY, Sept. 28 (HealthDay News) -- A child-size, single-use face mask to help prevent the spread of germs in hospitals and other health care settings has been approved by the U.S. Food and Drug Administration.

The mask is designed to prevent transmission of bacteria, viruses and other germs by children aged 5 years to 12 years. The product is specially designed for children, who do not breathe as forcefully as adults, the FDA noted in a news release.

The mask comes with important instructions for proper fitting by an adult, the agency said. The product shouldn't be used on children with symptoms of shortness of breath, chest pain, chest pressure, dizziness or confusion.

The mask is produced by Kimberly-Clark, based in Dallas.

More information

The FDA has more about this approval.

MONDAY, Sept. 26 (HealthDay News) -- Remicade (infliximab) has been approved by the U.S. Food and Drug Administration to treat moderate-to-severe active episodes of ulcerative colitis in children aged six and older who haven't responded to other therapies.

UC, a form of inflammatory bowel disease, attacks the lining of the large intestine and rectum. Symptoms may include abdominal pain, diarrhea, rectal bleeding, loss of weight and fever. Some 40 percent of the 50,000 to 100,000 children in the United States with inflammatory bowel disease have UC, the FDA said in a news release.

Remicade is a tumor necrosis factor blocker, which suppresses a bodily substance that causes inflammation and plays a role in so-called autoimmune diseases, in which the overactive immune system attacks the body itself.

Remicade has been FDA approved to treat UC in adults and to fight other autoimmune diseases among adults and children, including Crohn's disease, rheumatoid arthritis, plaque psoriasis, psoriatic arthritis and ankylosing spondylitis, the FDA said.

The drug carries a boxed label warning for increased risk of cancer and serious infections including tuberculosis, the agency said. As such, children should have all recommended vaccines before starting Remicade, the FDA said.

Other side effects of Remicade may include worsening of some UC symptoms and headache, the agency said.

Remicade is produced by Janssen Biotech, based in Malvern, Penn.

More information

To learn more about UC, visit Medline Plus.

FRIDAY, Sept. 23 (HealthDay News) -- Soliris (eculizumab) has been approved by the U.S. Food and Drug Administration as the first drug to treat atypical hemolytic uremic syndrome (aHUS), a rare blood disease that may trigger kidney failure, stroke or death.

Most people with aHUS are children, the FDA said in a news release. The atypical form affects up to 10 percent of all cases of hemolytic uremic syndrome.

Solaris was first approved in 2007 to treat another rare blood disorder, paroxysmal nocturnal hemoglobinuria (PNH). In people with aHUS, the drug limits the activities of proteins that play a role in the disease, the FDA said.

Soliris has been classified as an orphan drug, the agency said, meaning the drug has demonstrated promise in treating rare diseases or conditions.

In clinical testing of people with aHUS, Soliris' most common side effects included high blood pressure, diarrhea, headache, anemia, nausea and vomiting, infections of the upper respiratory tract and urinary tract, and a decrease in white blood cells.

The drug may also increase users' risk of life-threatening meningococcal infections. It will continue to be made available only via a restricted delivery program, under which prescribers must register with the FDA, the agency said.

Soliris is marketed by Alexion Pharmaceuticals, based in Cheshire, Conn.

More information

The FDA has more about this approval.

MONDAY, Sept. 19 (HealthDay News) -- The U.S. Food and Drug Administration has expanded approval for the Amgen bone-building drug Prolia (denosumab) to include prostate cancer or breast cancer patients who are taking certain hormonal therapies.

The drug was initially approved in 2010 to help prevent osteoporosis in post-menopausal women.

Breast cancer patients who use a class of hormone therapy known as aromatase inhibitors to limit estrogen production, and prostate cancer patients who are treated with hormones that limit production of androgens (including testosterone), may be at greater risk of bone fracture.

Amgen is based in Thousand Oaks, Calif.

More information

The FDA has more about this drug.

FRIDAY, Sept. 2 (HealthDay News) -- A kit to diagnose seasonal influenza, bird flu and other forms of flu that affect people has been approved by the U.S. Food and Drug Administration.

The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel was developed by the U.S. Centers for Disease Control and Prevention, which issued a news release announcing the approval. The kit utilizes specimens taken from the upper or lower respiratory tracts.

"The CDC test kit will be given at no cost to qualified international public health laboratories to improve global laboratory capacity for detecting influenza virus infections in human respiratory tract specimens," the release said.

"In helping public health officials quickly identify seasonal flu as well as the flu viruses that could become pandemic, this kit can make a real difference in protecting health and saving lives in the United States and around the world," the statement added.

More information

To learn more about influenza, visit the U.S. government's flu.gov website.

MONDAY, Aug. 29 (HealthDay News) -- Xalkori (crizotinib) and a companion diagnostic test have been approved by the U.S. Food and Drug Administration to treat advanced non-small cell lung cancer (NSCLC) with a certain genetic abnormality, the agency said in a news release.

The test and drug are aimed at NSCLC cancers that express an abnormal anaplastic lymphoma kinase (ALK) gene, which triggers cancer development and growth. About 1 percent to 7 percent of NSCLC cancers have the gene abnormality, the FDA said. Most people with this form of lung cancer are nonsmokers.

The drug's safety and effectiveness were established in a pair of clinical studies involving a total of 255 patients with late-stage ALK-positive NSCLC. Accelerated approval was granted under a program that allows the agency to approve a medication if it is "reasonably likely to predict a clinical benefit to patients," the FDA said.

The most common side effects of Xalkori included vision problems, nausea, diarrhea, vomiting, swelling and constipation. The drug also has been associated with potentially life-threatening inflammation of lung tissue (pneumonitis).

Xalkori is marketed by Pfizer, based in New York City.

More information

Visit the U.S. Food and Drug Administration to learn more about this approval.

FRIDAY, Aug. 26 (HealthDay News) -- Nucynta ER (tapentadol extended release) has been approved by the U.S. Food and Drug Administration to treat moderate-to-severe chronic pain in adults, maker Janssen Pharmaceuticals said.

The extended-release version of the opioid drug is taken twice daily. The original formulation of Nucynta was approved by the FDA in 2008.

Almost one-third of Americans will have chronic pain at some point in their lives, making it the most common form of long-term disability, the drug maker said.

In clinical testing of Nucynta, the most common side effects were nausea, constipation, headache and dizziness. People taking the drug must not consume alcohol or any medications that contain alcohol, Janssen said in a news release.

Janssen is a unit of Johnson & Johnson, New Brunswick, N.J.

More information

Medline Plus has more about this drug.

THURSDAY, Aug. 25 (HealthDay News) -- Firazyr (icatibant) has been approved by the U.S. Food and Drug Administration to treat acute (severe) attacks of hereditary angiodema (HAE) in adults.

The rare genetic condition is caused by low amounts of a protein called C1 inhibitor. Fewer than 30,000 people in the United States have the condition, the agency said in a news release. It causes potential symptoms including rapid swelling of the hands, feet, limbs, face, intestines and voice pipe.

Airway swelling puts victims at risk of suffocation, the FDA said.

The drug's safety and effectiveness were evaluated in clinical testing involving 225 patients. Symptom relief took an average of two hours among people who took the drug, versus almost 20 hours among those who took a placebo, the agency said.

Common side effects included injection site reactions, fever, an increase in liver enzymes, dizziness and rash.

Two other drugs, Berinert and Kalbitor, were approved previously to treat symptoms of HAE, the FDA said.

Firazyr is marketed by Shire Human Genetic Therapies, based in Cambridge, Mass.

More information

The U.S. Hereditary Angiodema Association has more about this condition.

WEDNESDAY, Aug. 24 (HealthDay News) -- Botox (onabotulinumtoxinA) has been approved by the U.S. Food and Drug Administration to treat urinary incontinence in people with neurological conditions such as spinal cord injury and multiple sclerosis.

Some people with these conditions have uncontrolled bladder contractions, which leads to inability to retain urine. Common treatments include medication or a catheter, the agency said in a news release.

The use of Botox involves injecting the drug into the bladder, relaxing the bladder. The drug's effects last for about nine months, the FDA said.

Botox was evaluated for this use in clinical studies involving 691 people. The most common adverse reactions included urinary tract infection and urinary retention.

Botox also is FDA-approved for reducing facial frown lines, and treating chronic migraine, certain forms of muscle stiffness, severe underarm sweating and abnormal twitches of the eyelid.

The drug is marketed by Irvine, Calif.-based Allergan Inc.

More information

To learn more about incontinence, visit the U.S. National Library of Medicine.

FRIDAY, Aug. 19 (HealthDay News) -- A new treatment called Adcetris (brentuximab vedotin) has been approved by the U.S. Food and Drug Administration to treat Hodgkin's lymphoma (HL) and a rare type of lymphatic-system cancer called systemic anaplastic large cell lymphoma (ALCL).

The antibody-drug combination directs an antibody at a type of lymphoma cell called CD30, the agency said in a news release.

Adcetris is the first treatment to combat Hodgkin's lymphoma approved by the FDA since 1977, and the first one designed to treat ALCL, the agency said.

In clinical testing, the most common reported side effects of Adcetris were a decrease in white blood cells, nerve damage, fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting and low levels of blood platelets.

The agency release also advised pregnant women that the treatment could harm a fetus, but did not say how.

The treatment is marketed by Washington state-based Seattle Genetics.

More information

The FDA has more about this approval.

WEDNESDAY, Aug. 17 (HealthDay News) -- Zelboraf (vemurafenib) has been approved by the U.S. Food and Drug Administration to treat a certain form of metastatic (spreading) melanoma, or cases that cannot be removed surgically, the agency said Wednesday.

The drug was approved to treat melanoma tumors with a gene mutation called BRAF V600E. Zelboraf was not studied in melanoma cases that did not include this abnormal gene, the FDA said in a news release.

The drug was approved along with a novel diagnostic test called the cobas 4800 BRAF V600 Mutation Test, which helps determine if melanoma cells have the gene mutation, the FDA said.

Zelboraf, a BRAF inhibitor, was evaluated in a clinical study of 675 people with late-stage melanoma that included the mutated gene. Of those who received Zelboraf, 77 percent were still living as of the agency's news release, compared with 64 percent still living who took a different anti-cancer drug.

The most common side effects among those who took Zelboraf included joint pain, rash, hair loss, fatigue, nausea, and skin sensitivity to the sun. About 26 percent of those treated with Zelboraf developed a form of skin cancer called cutaneous squamous cell carcinoma, which was treated with surgery, the FDA said.

People treated with Zelboraf should avoid exposure to the sun, the agency advised.

Both the drug and the screening test are manufactured by member companies of the Roche Group, based in Switzerland.

More information

The FDA has more about this approval.

THURSDAY, Aug. 4 (HealthDay News) -- Anascorp, the first injection devised solely to treat scorpion stings, has been approved by the U.S. Food and Drug Administration.

Venomous scorpions in the United States are primarily found in Arizona. Severe strings occur most often in babies and children, causing problems including shortness of breath, fluid in the lungs, difficulty breathing, increased saliva production, blurred vision and slurred speech, the agency said in a news release.

Since Anascorp is produced from the blood plasma of horses that have been immunized with scorpion venom, people who are sensitive to horse proteins may have an allergic reaction to the product, the FDA said. The manufacturing process includes steps designed to decrease the chances of an allergic reaction, and to thwart transmission of plasma-borne viruses, the agency added.

In clinical testing, Anascorp within four hours reduced neurological symptoms of scorpion stings among all eight children treated with the product. But neurological symptoms eased within four hours in only one of seven children who were given a placebo, the FDA said.

Reported side effects of Anascorp included vomiting, fever, rash, nausea, itchiness, headache, runny nose and muscle pain.

Anascorp is licensed to Tennessee-based Rare Disease Therapeutics, is distributed by Tennessee-based Accredo Health Group, and is manufactured by Mexico-based Instituto Bioclon.

More information

To learn more about scorpion stings, visit Medline Plus.

THURSDAY, July 21 (HealthDay News) -- Brilinta (ticagrelor) has been approved by the U.S. Food and Drug Administration to help reduce the risk of heart attack and cardiovascular death among people with acute coronary syndromes (ACS).

ACS is an umbrella term for any condition caused by reduced blood flow to the heart, such as unstable angina or heart attack. Blood-thinning Brilinta helps prevent clots that could impede cardiovascular blood flow, the FDA said in a news release.

The drug was studied in tandem with aspirin use. However, Brilinta's label will warn that its effectiveness will be impaired if people take aspirin in doses higher than 100 mg. per day, the FDA said.

The boxed label warning also specifies that Brilinta could lead to significant, possibly fatal, bleeding, a common label warning for blood-thinning drugs, the agency said.

As a condition of approval, drug maker AstraZeneca must take steps to alert doctors of the risk of using higher doses of aspirin.

More information

The FDA has more about this approval.

MONDAY, July 18 (HealthDay News) -- The 2011-12 influenza vaccine, containing the three strains predicted most common in the upcoming season, has been approved by the U.S. Food and Drug Administration.

Six manufacturers will be licensed to produce the vaccine, which also includes the same viral strains used for the 2010-11 flu season, the agency said in a news release.

The new strains include:

• A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus),
• A/Perth /16/2009 (H3N2)-like virus,
• B/Brisbane/60/2008-like virus.

The U.S. Centers for Disease Control and Prevention recommends that anyone 6 months and older get the annual vaccine. Each year, about 5 percent to 20 percent of the U.S. population develops flu, leading to more than 200,000 hospitalizations and 3,000 to 49,000 deaths, the FDA said.

While the predicted strains may not match the strains that wind up causing the most illness, the annual shot can still help reduce the respiratory disease's severity and may help prevent complications, the FDA said.

More information

To learn more about flu vaccination, visit the CDC.

MONDAY, July 11 (HealthDay News) -- Approval for the Boostrix vaccine has been expanded by the U.S. Food and Drug Administration to prevent tetanus, diphtheria and pertussis (whooping cough) in people 65 and older, the agency said in a news release.

While other vaccines exist to prevent tetanus and diphtheria among seniors, this is the first single booster shot to prevent all three diseases among this age group, the FDA said.

The vaccine's safety and effectiveness were evaluated in trials involving some 1,300 people aged 65 and older. The most common adverse reactions reported were headache, fatigue and injection-site pain.

The vaccine was initially approved in May 2005 for people aged 10 through 18. Approval was widened in December 2008 to include adults aged 19 through 64.

The product is manufactured by GlaxoSmithKline Biologicals, based in Belgium.

More information

The FDA has more about this approval.

TUESDAY, July 5 (HealthDay News) -- The Arcapta Neohaler (indacaterol inhalation powder) has been approved by the U.S. Food and Drug Administration for the long-term treatment of chronic obstructive pulmonary disease (COPD).

COPD symptoms include airflow obstruction, breathlessness, chronic cough and excessive phlegm, the agency said in a news release. Cigarette smoking is a primary cause of COPD, which includes chronic bronchitis or emphysema.

Arcepta, among a class of drugs called beta2-adrenergic agonists, helps relax the lung's airways. It is not intended to treat asthma or the sudden, severe onset of breathing problems associated with COPD, the FDA said.

The inhaler was evaluated in a series of clinical studies involving nearly 5,500 people aged 40 and older who had been diagnosed with COPD. Participants all had smoked at least a pack of cigarettes per day for 10 years, and had demonstrated reduced lung function. The most common side effects reported were runny nose, cough, sore throat, headache and nausea.

The Arcepta Neohaler carries a boxed label warning that it increases the risk of asthma-related death. The product should not be used in people with asthma, unless used with a long-term asthma control medication, the FDA said.

The product is marketed by Novartis Pharmaceuticals, based in East Hanover, N.J.

More information

To learn more about COPD, visit Medline Plus.

FRIDAY, July 1 (HealthDay News) -- Lazanda (fentanyl) nasal spray has been approved by the U.S. Food and Drug Administration to treat breakthrough pain in adults with cancer who are already receiving opioid therapy, drug maker Archimedes Pharma said.

Breakthrough pain occurs as an intense, unpredictable burst among people who are already receiving therapy for chronic pain. Lazanda is the first nasal spray containing the commonly prescribed opioid painkiller fentanyl, the company said in a news release. Lazanda is available in five European countries under the brand name PecFent.

Lazanda will be prescribed under a Risk Evaluation and Mitigation Strategy (REMS) program to minimize instances of abuse and addiction, the drug maker said. The program requires pharmacies, distributors and doctors who prescribe the medication to enroll.

The drug's safety and effectiveness were established in clinical studies involving more than 500 people, Archimedes said. The most common adverse reactions were vomiting, nausea, fever and constipation.

Archimedes, headquartered in England, has a U.S. subsidiary based in Bedminister, N.J.

More information

The U.S. National Institute on Drug Abuse has more about fentanyl.

MONDAY, June 20 (HealthDay News) -- The first generic versions of levofloxacin, prescribed under the brand name Levaquin, have been approved by the U.S. Food and Drug Administration.

The antibiotic is sanctioned for infections of the skin, sinuses, kidneys, bladder or prostate, as well as certain strains of bacterial bronchitis or pneumonia, the agency said in a news release.

The generic versions, licensed to be produced by 12 manufacturers, is chemically equivalent to the brand-name drug. It belongs to a class of drugs called fluoroquinolones, which have a boxed label warning for increased risk of tendonitis and tendon rupture. The risk is higher among people 60 and older, among people who take corticosteroid drugs, and among people who have had kidney, heart or lung transplants, the FDA said.

More information

To learn more about this drug, visit the U.S. National Library of Medicine.

MONDAY, June 20 (HealthDay News) -- Oxecta, an abuse-resistant form of the top-selling painkiller oxycodone, has been approved by the U.S. Food and Drug Administration.

The immediate-release medication contains niacin, which is designed to cause uncomfortable flushing and skin irritation if a person takes more than the recommended amount. Oxecta is similar to Purdue Pharma's best-selling prescription painkiller Oxycontin, a long-acting opioid drug that's commonly abused.

Oxecta shouldn't be used in people who have severe asthma, upper-airway obstruction or chronic obstructive pulmonary disease (COPD), drug makers Pfizer and Acura Pharmaceuticals said in a news release. Common adverse reactions include nausea, constipation, vomiting, headache, itchiness, insomnia, dizziness and lack of energy, the companies said.

Pfizer is based in New York City, and Acura in Palatine, Ill.

More information

The National Library of Medicine has more about oxycodone.

THURSDAY, June 16 (HealthDay News) -- Nulojix (belatacept) has been approved by the U.S. Food and Drug Administration to prevent rejection of a transplanted kidney in adults.

The immunosuppressant drug is among a class called selective T-cell costimulation blockers. Without immune-suppressing drugs, the immune system could recognize the transplanted organ as foreign, leading to organ rejection, the agency said in a news release.

Nulojix was considered safe and effective after being evaluated in clinical studies involving more than 1,200 patients. Common adverse reactions recorded during the trials included anemia, constipation, kidney infection, and swelling of the ankles, legs or feet, the FDA said.

The new drug, designed to be injected with other immunosuppressants, will carry a boxed warning for increased risk of post-transplant lymphoproliferative disorder (PTLD), a form of cancer characterized by excessive white blood cell growth after an organ transplant. A separate label warning will note an increased risk of other forms of cancer, as well as serious infections, the FDA said.

Nulojix is marketed by Bristol-Myers Squibb, Princeton, N.J.

More information

Medline Plus has more about kidney transplant.

TUESDAY, June 14 (HealthDay News) -- The first ceramic-on-metal total hip replacement system has been approved by the U.S. Food and Drug Administration.

The Pinnacle Complete Acetabular Hip System, combining a ceramic ball and a metal socket, has been sanctioned for people with osteoarthritis, the agency said in a news release.

Approval was based on a two-year study that found no clinical difference between 194 people who received the new ceramic-on-metal system and 196 people who received a metal-on-metal device, the FDA said.

The maker of the new device, DePuy Orthopaedics, is required to conduct a post-approval study to evaluate any long-term adverse effects and metal ion concentrations in the blood, the agency said.

DePuy is based in Warsaw, Ind.

More information

Medline Plus has more about hip replacement.

TUESDAY, June 14 (HealthDay News) -- A genetic test to help doctors evaluate whether women with breast cancer are candidates for treatment with the drug Herceptin (trastuzumab) has been approved by the U.S. Food and Drug Administration.

The Inform Dual ISH test measures whether there are excessive copies of the HER2 gene in breast tumor tissue. HER2-positive breast cancer is a fast-growing, aggressive form of the disease, making up about 20 percent of all breast cancer cases, the FDA said in a news release. Women with an above-normal number of copies of the HER2 gene are candidates for Herceptin therapy.

Clinical studies involving 510 women with breast cancer showed the new test was 96 percent accurate in identifying HER2-positive tumor samples, the agency said. The test correctly identified HER2-negative tumors in 92.3 percent of cases.

Breast cancer is the second-leading cause of cancer deaths among women, the FDA said, citing some 207,090 cases diagnosed in the United States last year, and about 39,840 deaths from the disease.

The new test is produced by Ventana Medical Systems, based in Tucson, Ariz.

More information

The U.S. National Institutes of Health has more about breast cancer.

FRIDAY, June 10 (HealthDay News) -- The first device to perform simultaneous PET (position emission tomography) and MRI (magnetic resonance imaging) scans has been approved by the U.S. Food and Drug Administration, the agency said Friday.

PET scans involve injection of a radioactive tracer into the bloodstream, which gives doctors a glimpse of internal organs and tissue. MRI uses a magnetic field and radio waves to create detailed images of the body's organs, soft tissue and bones.

The Siemens Biograph mMR system creates both types of images at the same time, lowering overall radiation exposure and preventing the need to move a patient to two different scanners, the FDA said in a news release.

As with stand-alone MRIs, people with pacemakers, defibrillators and other implanted electronic devices should avoid the new system, since the scanner's strong magnetic fields could interfere with those devices, the agency said.

Siemens Medical Solutions is based in Malvern, Penn.

More information

Cleveland Clinic has more about PET scans and MRIs.

TUESDAY, May 31 (HealthDay News) -- Solesta gel has been approved by the U.S. Food and Drug Administration to treat fecal incontinence in adults after other therapies have failed.

The sterile substance is injected into the layer of tissue beneath the anal lining. Approval was sanctioned for people in whom therapies such as modified diet, fiber therapy, or medication haven't worked, the agency said in a news release.

Loss of bowel control can result from nerve damage, muscle damage, or certain effects of aging. More than 5.5 million Americans have fecal incontinence, U.S. Government statistics show.

Solesta was evaluated in clinical studies involving 206 people. The most common side effects included injection-site pain and bleeding, and less frequently, infection and inflammation of anal tissue. The gel should not be used in people with active inflammatory bowel disease, immune disorders, or active infection, bleeding or tumors, the FDA said.

Solesta is produced by Oceana Therapeutics, based in Edison, N.J.

More information

The National Digestive Diseases Information Clearinghouse has more about fecal incontinence.

TUESDAY, May 31 (HealthDay News) -- Dificid (fidaxomicin) has been approved by the U.S. Food and Drug Administration to treat diarrhea associated with Clostridium difficile infection.

The bacterial illness, commonly acquired by the elderly and others with weakened immune systems in hospitals and group settings, is abbreviated C. diff. It is easily passed from person to person by touching contaminated surfaces, the FDA said in a news release.

The infection frequently causes diarrhea, can lead to colitis and other intestinal conditions, and may cause death in severe cases, the agency said. In some people, the illness can recur.

Dificid was evaluated in clinical studies involving 564 people with C. diff-associated diarrhea. More people who took Dificid were still symptom-free three weeks after stopping treatment than those who took a common antibiotic, vancomycin, the FDA said.

Recommended dosage with Dificid is twice daily for 10 days. The most common side effects reported included nausea, vomiting, headache, abdominal pain and diarrhea.

Dificid was developed by Optimer Pharmaceuticals, based in San Diego.

More information

To learn more about this illness, visit the U.S. Centers for Disease Control and Prevention.

MONDAY, May 23 (HealthDay News) -- Incivek (telaprevir) has been approved by the U.S. Food and Drug Administration for adults with chronic hepatitis C infection who either haven't received standard interferon therapy or haven't responded to it.

The standard treatment for the chronic liver disease is a combination of peginterferon alfa and ribavirin, taken for 48 weeks. But fewer than half of people with chronic hepatitis C given this therapy respond to it, the FDA said in a news release.

Incivek, combined with standard interferon therapy, was evaluated in clinical studies involving about 2,250 people. Among those previously untreated, 79 percent had no hepatitis C infection detected in the blood 24 weeks after stopping treatment. This was 20 percent to 45 percent higher than people who received standard therapy alone, the FDA said.

Chronic hepatitis C infection often leads to cirrhosis of the liver, which can cause complications including bleeding, jaundice, abdominal fluid buildup or liver cancer, the agency said.

Most people who received the Incivek regimen were able to stop treatment within 24 weeks, rather than the recommended 48 weeks, the FDA said. Common side effects of the treatment included rash, anemia, nausea, fatigue, headache and diarrhea.

Incivek, marketed by Massachusetts-based Vertex Pharmaceuticals, is the second hepatitis C drug approved by the FDA this month. On May 13, the agency sanctioned Merck & Co.'s Victrelis.

More information

To learn more about hepatitis C, visit the U.S. Department of Veteran Affairs.

MONDAY, May 23 (HealthDay News) -- U.S. Food and Drug Administration approval of Sutent (sunitinib) has been expanded to include people with neuroendocrine pancreatic cancer that is inoperable or has metastasized to other parts of the body.

Neuroendocrine tumors are slow-growing and affect fewer than 1,000 people each year in the United States, the FDA said in a news release.

Pfizer's Sutent was previously FDA approved to treat late-stage kidney cancer and gastrointestinal stromal tumor (GIST), a rare cancer of the stomach, bowel or esophagus.

Among people with neuroendocine pancreatic cancer, Sutent in clinical trials extended average lifespan to 10.2 months, compared to 5.4 months among people who took a placebo. The most common side effects included diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure and stomach pain.

Pfizer is based in New York City.

More information

The Dana-Farber Cancer Institute has more about this type of cancer.

FRIDAY, May 20 (HealthDay News) -- The first test to detect Q fever in soldiers and other members of the military serving overseas has been approved by the U.S. Food and Drug Administration.

Q fever, caused by an infection from the bacterium Coxiella burnetii, is affecting soldiers serving in Iraq and elsewhere, the FDA said in a news release. Victims usually recover completely if the infection is detected and treated early with antibiotics. But left untreated, it can cause chronic illness.

Citing the U.S. Centers for Disease Control and Prevention, the FDA said Q fever was first recognized in Australia in 1935, and in the United States in the early 1940s.

The new diagnostic was developed by Idaho Technology Inc., based in Salt Lake City.

More information

The U.S. National Institutes of Health has more about Q fever.

FRIDAY, May 20 (HealthDay News) -- Edurant (rilpivirine), in combination with other antiretroviral drugs, has been approved by the U.S. Food and Drug Administration to treat HIV-1 infection in adults who haven't taken any prior HIV therapy

HIV is the virus that causes AIDS. Edurant, a so-called non-nucleoside reverse transcriptase inhibitor (NNRTI), blocks the virus's ability to reproduce itself. The pill is taken once daily with food, the FDA said in a news release.

Edurant was evaluated in a pair of 48-week studies involving 1,368 adults infected with HIV. Compared to another NNRTI, efavirenz, Edurant was as effective in lowering amounts of the virus in a person's blood, the agency said.

The most common adverse reactions reported were depression, insomnia, headache and rash.

Since Edurant does not reverse HIV infection, people must continue taking the drug, in combination with other anti-HIV medications, to prevent HIV-related illness, the FDA said.

Edurant is produced by Tibotec Therapeutics, based in Raritan, N.J.

More information

Visit aids.gov to learn more about HIV/AIDS.

THURSDAY, May 19 (HealthDay News) -- A new test to detect whether a toxoplasmosis infection has been acquired within the past four months has been approved by the U.S. Food and Drug Administration.

The Vidas Toxo IgG Avidity Assay -- approved for people with a toxoplasmosis infection confirmed by other methods -- can be used to validate whether infection by the Toxoplasma gondii parasite is less than four months old. Human antibodies triggered by the parasite behave differently after four months than they do initially.

Toxoplasmosis, sometimes called "cat scratch disease" can be passed from mother to unborn child. The infection can cause miscarriage, stillbirth or an abnormally sized fetal head. In the child's later life, it can lead to vision loss, mental impairment or seizures, the FDA said in a news release.

While exposure to cats and used cat litter are primary methods of transmission, toxoplasmosis also can be transmitted by other animals and birds. And the parasite can be acquired by eating raw or undercooked meat. Typical warning signs among people include swollen lymph nodes and flu-like symptoms, the FDA said.

The test is produced by bioMerieux Inc., based in Hazelwood, Mo.

More information

The U.S. Centers for Disease Control and Prevention has more about toxoplasmosis.

MONDAY, May 16 (HealthDay News) -- Victrelis (boceprevir) has been approved by the U.S. Food and Drug Administration to treat chronic hepatitis C, in tandem with the two additional drugs, pegylated interferon alfa and ribavirin.

Victrelis was evaluated in a pair of clinical trials involving 1,500 adults. Among those who used the three-drug combination, more had a sustained virologic response than people who used pegylated interferon alfa and ribavirin alone, the FDA said in a news release. Sustained virologic response was achieved when the hepatitis C virus was no longer detected in the blood six months after stopping treatment.

Some 3.2 million people in the United States have chronic hepatitis C, the FDA said, citing U.S. Centers for Disease Control and Prevention statistics. The viral infection causes inflammation of the liver, which can lead to reduced liver function and liver failure. Most people with the disease have no symptoms until the onset of liver damage, the agency said.

Victrelis is taken three times daily with food. Common adverse reactions include fatigue, anemia, nausea, headache and taste distortion.

The drug is marketed by Merck & Co., based in Whitehouse Station, N.J.

More information

To learn more about hepatitis, visit the CDC.

FRIDAY, May 6 (HealthDay News) -- The first Staphylococcus aureus diagnostic that can quickly identify the staph bacterium and whether it's resistant to methicillin and similar antibiotics has been approved by the U.S. Food and Drug Administration.

Staphylococci bacteria can cause a number of maladies, including pneumonia, blood poisoning and certain skin infections. Some of the infections may respond to antibiotics such as methicillin and are called methicillin susceptible (MSSA), while other strains are known as methicillin resistant (MRSA).

The KeyPath MRSA/MSSA Blood Culture Test is able to distinguish between the two types of infection within about five hours, the FDA said in a news release.

MRSA infections, while they can develop anywhere, often appear in hospital and other health care settings, where many patients have weakened immune systems.

The new diagnostic was evaluated in clinical studies involving 1,116 people at four major U.S. hospital centers. The test was 98.9 percent accurate in identifying MRSA, and 99.4 percent accurate in identifying MSSA, the FDA said.

The test is produced by MicroPhage Inc., based in Longmont, Colo.

More information

To learn more about MRSA infections, visit the U.S. Centers for Disease Control and Prevention.

FRIDAY, May 6 (HealthDay News) -- More people with a clogged neck artery are now candidates for the RX Acculink carotid stent, the U.S. Food and Drug Administration said Friday.

The agency widened approval for the device to include all people with a clogged carotid artery who are at risk for stroke, not just those who don't qualify for artery-clearing surgery, the agency said in a news release.

Carotid arteries on both sides of the neck feed blood to the brain. If clogged with fatty deposits called plaque, the resulting lack of blood could lead to a stroke.

In 2004, the RX Acculink stent was first FDA-approved for people at high risk of complications if they had artery-clearing surgery known as carotid endarterectomy.

Earlier this year, an expert panel advising the FDA concluded that RX Acculink was generally safe and effective for the new group of candidates. But the panel recommended long-term studies to evaluate the stent's use when combined with another device designed to capture any debris that might break away from the clogged area, the FDA said.

The agency said as a condition of approval, it's requiring device maker Abbott Vascular to conduct a post-approval trial of at least three years. The company is based in Santa Clara, Calif.

More information

To learn more about carotid artery disease, visit Medline Plus.

FRIDAY, May 6 (HealthDay News) -- U.S. Food and Drug Administration approval of Afinitor (everolimus) has been expanded to include people with progressive neuroendocrine tumors of the pancreas (PNET) that have spread to other parts of the body or cannot be removed by surgery, the agency said Friday.

PNET is slow-growing and rare, affecting fewer than 1,000 new patients in the United States each year, the FDA said in a news release.

Afinitor was evaluated in clinical trials involving 410 people with late-stage or advancing forms of this cancer. Those treated with Afinitor survived without the cancer worsening for an average of 11 months, compared with 4.6 months among people who took a placebo, the agency said.

The most common side effects reported included mouth inflammation, rash, diarrhea, fatigue, swelling, stomach pain, nausea, fever and headache.

Afinitor was previously FDA-approved for advanced kidney cancer and certain brain tumors that cannot be treated surgically.

The drug is marketed by Novartis, based in East Hanover, N.J.

More information

The FDA has more about this approval.

MONDAY, May 2 (HealthDay News) -- Tradjenta (linagliptin) tablets, combined with diet and exercise, has been approved by the U.S. Food and Drug Administration to control blood sugar in people with type 2 diabetes, the agency said Monday.

People with type 2 diabetes don't produce the pancreatic hormone insulin, or don't respond to it properly. Insulin helps control the levels of sugar (glucose) in a person's blood. People with too much blood sugar at are risk of serious complications including heart disease, blindness, kidney damage, and nerve damage, the FDA said in a news release.

Type 2 diabetes is the disease's most common form, affecting up to 95 percent of the estimated 24 million people with diabetes in the United States, the FDA said.

Tradjenta boosts hormones that stimulate the release of insulin after a person eats. The drug was evaluated in clinical trials involving 3,800 people with type 2 diabetes. The most common adverse reactions reported included upper respiratory infection, stuffy nose, sore throat, muscle pain and headache.

Tradjenta should not be used by people with type 1 diabetes or by those who have above-normal levels of ketones in their blood or urine, the agency advised.

The drug is co-marketed by Ridgefield, Conn.-based Boehringer Ingelheim Pharmaceuticals and Indianapolis-based Eli Lilly and Co.

More information

To learn more about type 2 diabetes, visit the National Diabetes Information Clearinghouse.

FRIDAY, April 29 (HealthDay News) -- Zytiga (abiraterone acetate), used in combination with the steroid prednisone, has been approved to treat advanced prostate cancer, the U.S. Food and Drug Administration said in a news release.

The growth of cancerous prostate tumors is fueled by the male hormone testosterone, and the new drug combination blocks a protein that plays a key role in body's production of testosterone, the agency said.

Zytiga was evaluated in clinical studies involving 1,195 men with advanced prostate cancer whose tumors continued to grow despite chemotherapy. Men who received the Zytiga/prednisone combination lived an average of 14.8 months, compared with 10.9 months among men who took a placebo, the FDA said.

The most common adverse reactions to the drug combination included joint discomfort, low blood potassium, fluid retention, muscle discomfort, hot flashes, diarrhea, urinary tract infection, cough, high blood pressure, heartbeat abnormalities, increased urinary frequency, upset stomach and upper respiratory infection.

Zytiga is produced by Centocor Ortho Biotech, based in Horsham, Pa.

More information

To learn more about prostate cancer, visit the U.S. National Cancer Institute.

MONDAY, April 25 (HealthDay News) -- Use of the Menactra vaccine has been expanded by the U.S. Food and Drug Administration to prevent meningitis and other forms of meningococcal disease in children as young as 9 months, the agency said in a news release.

Menactra is already approved to prevent meningococcal disease in people aged 2 years to 55. The deadly Neisseria meningitidis bacteria infect the bloodstream and lining that surrounds the brain and spinal cord. Despite treatment, as many as 15 percent of people who contract meningitis and related diseases die from the infection, the FDA said. As many as 20 percent who survive suffer severe complications, which may include brain damage, loss of limb or loss of hearing.

Infants and toddlers are more susceptible than older people to the illness, which may cause death within hours of onset, the agency said. Early symptoms often are confused with those of the flu.

Menactra was evaluated in four clinical studies involving more than 3,700 infants and toddlers as young as 9 months. The most common adverse reactions included injection-site tenderness, irritability and fever.

Menactra was first approved in 2005 for people aged 11 to 55. In 2007, approval was expanded to include children as young as 2 years. The vaccine is produced by Sanofi Pasteur, based in Swiftwater, Penn.

More information

To learn more about vaccination for meningococcal disease, visit the U.S. Centers for Disease Control and Prevention.

WEDNESDAY, April 6 (HealthDay News) -- A new device to treat an arterial bulge (aneurysm) in the brain has been approved by the U.S. Food and Drug Administration.

Over time, a person's normal blood pressure can cause an aneurysm to grow larger and burst, which could be life-threatening. A ruptured brain aneurysm affects about 30,000 people each year in the United States, the FDA said in a news release, citing an estimate from the American Association of Neurological Surgeons.

Aneurysms are most common in people aged 50 to 60, and are three times more common in women than men, the FDA said.

The newly approved Pipeline Embolization Device is a metal mesh tube that is implanted in the internal carotid artery, a primary supplier of blood to the brain. The device is meant to cut off blood flow to the aneurysm and to reduce the likelihood of the artery's rupture, the agency said.

The device is implanted by feeding a catheter into the carotid artery via insertion into a leg artery. Aneurysms successfully treated with the device often shrink over time, the FDA said.

The product was evaluated in a clinical study involving 108 people aged 21 to 75 who had a certain type of aneurysm in the internal carotid artery. After one year, 70 percent of aneurysms remained blocked off without a meaningful narrowing (stenosis) of the affected section of artery, the FDA said.

The study found that ten strokes occurred among nine people in the year after initial treatment, the agency said. Minor adverse reactions included headache, bleeding, nausea and vision problems.

The device, made by Menlo Park, Calif.-based ev3, should not be used in people with an active infection or who cannot take medication that interferes with clotting, the FDA said.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more information about aneurysms affecting the brain.

WEDNESDAY, April 13 (HealthDay News) -- A new option to repair a difficult-to-manage bulging artery in the brain has been approved by the U.S. Food and Drug Administration.

Such a bulge, called an aneurysm, can grow and eventually burst. This can lead to a brain hemorrhage and even death.

Aneurysms larger than 10 millimeters, or those of an odd shape, often are difficult to treat. The cPAX Aneurysm Treatment System uses a special polymer to line the artery around the aneurysm, reducing the risk of rupture, the FDA said in a news release.

The system was approved under the agency's Humanitarian Device Exemption, which makes devices available for conditions affecting fewer than 4,000 people annually. The system was evaluated in small pair of clinical studies involving 43 people, the FDA said.

The cPAX system was approved for people 22 and older. It shouldn't be used in people with an active infection or among those who can't undergo anti-clotting therapy, the agency said.

The system is manufactured by Neurovasx Inc., of Maple Grove, Minn.

More information

The FDA has more about this approval.

MONDAY, April 11 (HealthDay News) -- The first test to help diagnose people with symptoms of the mosquito-borne virus dengue fever has been approved by the U.S. Food and Drug Administration.

As many as 100 million people globally are believed infected each year with the virus, transmitted by Aedes mosquitoes, the FDA said in a news release. Symptoms include high fever, severe headache and pain behind the eyes, pain in the joints, muscles and bones, rash, and easy bleeding and bruising.

Most cases in the continental United States can be traced to people returning from Latin America, the Caribbean and Southeast Asia. It's also common in Puerto Rico and the Virgin Islands. Recent dengue outbreaks have been reported in Hawaii, Texas and Florida, the FDA said.

The DENV Detect IgM Capture ELISA test detects dengue antibodies in the blood. The test is based on technology developed by the U.S. Centers for Disease Control and Prevention, and is manufactured by Inbios Inc., of Seattle.

The test should not be used in people who do not have any symptoms of dengue fever, the FDA warned. There are no FDA-approved vaccines to prevent the infection or medicines approved specifically to treat it, the agency said.

More information

The CDC has more about dengue fever.

FRIDAY, April 8 (HealthDay News) -- A test designed to rapidly detect the genetic fingerprint of Clostridium difficile (C. diff) bacterial infection has been approved by the U.S. Food and Drug Administration.

C. diff is an intestinal infection that's commonly acquired by the elderly, hospital patients, people at group living facilities or nursing homes, and by those taking an antibiotic for another infection. It's easily spread by touching contaminated surfaces.

C. diff infection causes diarrhea and intestinal inflammation, and can lead to complications including colitis, the FDA said in a news release.

The Cepheid Xpert C. difficile/Epi assay detects toxin gene sequences associated with the epidemic 027/NAP1/BI strain of the bacterium in a person's stool. However, the test should not be used to determine or monitor treatment, the agency warned.

The best way to prevent infection is via thorough hand-washing with soap and warm water, the FDA said.

The new test is produced by Cepheid, based in Sunnyvale, Calif.

More information

To learn more about this infection, visit the U.S. Centers for Disease Control and Prevention.

THURSDAY, April 7 (HealthDay News) -- Horizant extended release tablets (gabapentin enacarbil) have been approved as a once-daily treatment for restless legs syndrome (RLS), a disorder that causes a strong desire to move the legs.

The disorder creates unpleasant sensations in the legs, including itching, tingling, burning or aching, which are temporarily relieved by moving the legs. A person with RLS usually has these sensations when inactive, typically in the early morning and evening, the FDA said in a news release.

Horizant was evaluated in a pair of 12-week trials among adults with moderate-to-severe RLS. People who took the drug reported improvement in RLS symptoms, compared to those who took an inactive placebo.

The drug's common side effects include drowsiness and dizziness, which could impair a person's ability to drive or use heavy machinery. The body absorbs Horizant as gabapentin, a drug used to treat epilepsy. Horizant's label will include a warning that drugs used to treat epilepsy may lead to suicidal thoughts and actions in some people, the FDA said.

Horizant was developed by drugmakers GlaxoSmithKline and Xenoport.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about restless legs syndrome.

THURSDAY, April 7 (HealthDay News) -- Vandetanib has been approved by the U.S. Food and Drug Administration as the first drug to treat a rare form of thyroid cancer in its latter stages.

Medullary thyroid cancer accounts for 3 percent to 5 percent of the estimated 44,600 cases of thyroid cancer diagnosed each year in the United States, the FDA said in a news release. Typical symptoms include coughing, difficultly swallowing, thyroid enlargement, neck swelling, a lump on the thyroid and voice changes. Medullary thyroid cancer may occur spontaneously or be related to a genetic syndrome.

Vandetanib was evaluated in a study of 331 people with late-stage medullary thyroid cancer. Average progression-free survival among those who took the drug was 22.6 months, compared to 16.4 months among those who took an inactive placebo, the agency said.

Five people treated with the drug died from causes that included respiratory problems, heart failure and a bacterial blood infection called sepsis. Vandetanib also was shown to affect the electrical activity of the heart, which could result in life-threatening irregular heartbeat, the FDA said.

The most common side effects reported were diarrhea, rash, nausea, high blood pressure, headache, fatigue, loss of appetite and abdominal pain.

Vandetanib is produced by AstraZeneca Pharmaceuticals, based in Wilmington, Del.

More information

To learn more about medullary thyroid cancer, visit the U.S. National Cancer Institute.

MONDAY, April 4 (HealthDay News) -- Medtronic's InterStim implanted electrical stimulation device has been approved by the U.S. Food and Drug Administration to help restore bowel control in people with chronic fecal incontinence, the company said in a news release.

InterStim -- comprised of a thin wire lead and an implanted pacemaker-like device -- uses mild electrical stimulation of the sacral nerves to affect pelvic muscles and the bowel. It improved or restored bowel control in 80 percent of people who failed more conservative therapies or weren't candidates for those therapies, Medtronic said.

The device had already been approved by the FDA to treat symptoms of overactive bladder and non-obstructive urinary retention, the company said.

The most common side effects reported during clinical testing included implant site pain, a sensation of skin tingling or numbness, and implant site infection.

More than 18 million Americans have fecal incontinence, according to U.S. Government statistics cited by Medtronic, based in Minneapolis.

More information

To learn more about fecal incontinence, visit the U.S. National Digestive Diseases Information Clearinghouse.

TUESDAY, March 29 (HealthDay News) -- Defibrillator maker Medtronic says its new line of Protecta devices has been approved by the U.S. Food and Drug Administration. The devices incorporate "Smart Shock" technology that recognizes when irregular heartbeats are life-threatening and delivers therapeutic shocks "only when appropriate," Medtronic said in a news release.

Implanted defibrillators are designed to shock an irregularly beating heart (ventricular arrhythmia) back into a normal rhythm. However, sometimes the devices sense a non-life-threatening arrhythmia or electrical noise and produce an "inappropriate shock," Medtronic said.

As many as one in five people with implantable defibrillators experiences inappropriate shocks, Medtronic said, adding its studies concluded that 98 percent of people with the Protecta devices were free of inappropriate shocks a year after implant.

Shipments of the new devices will begin immediately, said Medtronic, based in Minneapolis.

More information

To learn more about this type of device, visit the U.S. National Library of Medicine.

FRIDAY, March 25 (HealthDay News) -- The drug Yervoy (ipilimumab) has been approved by the U.S. Food and Drug Administration to treat late-stage melanoma, the deadliest form of skin cancer.

Citing statistics from the National Cancer Institute, the FDA said some 68,130 cases of melanoma were diagnosed in the United States last year, and about 8,700 people died from it.

Yervoy appears to block a molecule called CTLA-4 that is believed to slow or disable the immune system, hindering the body's ability to fight cancer, the FDA said in a news release.

The intravenous drug was evaluated in clinical studies of 676 people with melanoma. All had stopped responding to other FDA-approved melanoma treatments, the agency said, and participants' cancers had spread or could not be removed surgically.

Trial participants who received Yervoy lived an average of 10 months, while those who did not take the drug lived an average of 6.5 months. The most common adverse reactions included fatigue, diarrhea, skin rash and intestinal inflammation, the FDA said.

About 13 percent of users suffered severe-to-fatal autoimmune reactions. As a result, guides will be distributed with the drug, informing doctors and patients of the medication's potential risks, the agency said.

Yervoy is marketed by Bristol-Myers Squibb.

More information

The National Cancer Institute has more about melanoma.

THURSDAY, March 24 (HealthDay News) -- The Zostavax shingles vaccine is now approved by the U.S. Food and Drug Administration for people aged 50 and older.

FDA-sanctioned use of the vaccine, first approved in 2006, had been limited to people 60 and older. The expanded approval includes the about 200,000 people aged 50 to 59 who contract shingles each year, the agency said in a news release.

Shingles is caused by the same varicella-zoster virus that caused chickenpox when the affected people were younger. The virus lies dormant in the body until years later, when for reasons that aren't understood, it re-emerges as shingles -- commonly in older people with weakened immune systems.

Shingles is characterized by a painful blistery rash, often on one side of the body. In some people, the severe pain can last for months or years after shingles emerges, the FDA said.

The vaccine was clinically evaluated in some 22,000 people aged 50 to 59. Zostavax reduced the risk of acquiring shingles by about 70 percent, compared to people who received an inactive placebo, the agency said.

Commonly reported side effects of the vaccine included injection-site redness, pain and swelling.

Zostavax is manufactured by Merck & Co., based in Whitehouse Station, N.J.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about shingles.

TUESDAY, March 15 (HealthDay News) -- Gadavist (gadobutrol) has been approved by the U.S. Food and Drug Administration as a contrast agent for people having magnetic resonance imaging (MRI) of the central nervous system.

The gadolinium-based agent will help doctors detect lesions that affect the cell barrier between the brain and the blood stream, the FDA said in a news release. Approved for patients 2 years and older, the agent was evaluated in two clinical studies involving 657 patients.

Gadavast and similar agents include a boxed warning about the possibility of nephrogenic systemic fibrosis (NSF) in some people with kidney problems. NSF is a rare condition, characterized by thickening of the skin, that may lead to development of excess fibrous connective tissue in some internal organs. Gadavast, however, is thought to put users at lower risk of NSF, as compared to similar contrast agents, the FDA said.

The most common side effects reported during clinical testing of Gadavast included headache, nausea and so-called "hypersensitivity" reactions, the agency said.

Gadavast is produced by Bayer Pharmaceuticals, based in Wayne, N.J.

More information

The FDA has more about its label warnings for MRI contrast agents.

FRIDAY, March 11 (HealthDay News) -- A device that permits the rerouting of blood flow during surgery to treat a brain aneurysm or tumor in people at greater risk of stroke has been approved by the U.S. Food and Drug Administration.

The Excimer Laser Assisted Non-Occlusive Anastamosis (ELANA) Surgical Kit makes it possible for surgeons to bypass the aneurysm or tumor without clipping the affected artery and temporarily ending blood flow, the agency said in a news release.

About 1,000 people who have brain bypass surgery each year would be at higher-than-normal risk of stroke if the artery were clipped and blood flow stopped, the agency said. These patients -- 13 and older -- often have a weakened, enlarged area in a brain artery called a cerebral aneurysm, or a tumor at the base of the skull.

The ELANA kit was approved under the FDA's "Humanitarian Use Device" rules, meaning it's designed to treat or diagnose a condition that affects fewer than 4,000 people each year in the United States. Qualifying manufacturers must show that the device's benefits outweigh its risks, and that no similar device is already available.

The ELANA kit should not be used if the patient shows hardening of the arteries (arteriosclerosis) or artery calcification, the FDA warned.

The device is made by Elana, based in the Netherlands.

More information

To learn more about brain bypass surgery, visit HeartHealthyWomen.org.

THURSDAY, March 10 (HealthDay News) -- Benlysta (belimumab) has been approved by the U.S. Food and Drug Administration to treat lupus, the first medication sanctioned for the condition in the United States since 1955.

The injected drug targets B-lymphocyte stimulator (BLyS) protein, which is believed to play a role in abnormal B cells thought to characterize lupus, the agency said in a news release. Lupus is an autoimmune disease, in which the body's disease-fighting system attacks healthy tissue. The condition disproportionally affects women, usually aged 15 to 44. Symptoms commonly include joint pain and swelling, sensitivity to light, fever, chest pain, hair loss and fatigue.

In addition to the joints, lupus can affect the skin, kidneys, lungs, heart and brain. As many as 1.5 million people in the United States have the disease, although estimates vary widely, the FDA said. Black women have a three times higher incidence of the disease than Caucasian women.

The safety and effectiveness of Benlysta were established in a pair of clinical studies involving 1,684 people. Those treated with Benlysta had fewer symptoms than those who took a non-medicinal placebo, and the results suggested that those who took the drug also were less likely to have severe lupus flares, the agency said.

Common side effects of the drug included nausea, diarrhea and fever.

Blacks and people of African heritage didn't respond to the new drug, and the FDA said it ordered Benlysta's manufacturer to conduct additional studies involving these patients.

Benlysta was developed by Human Genome Sciences, based in Rockville, Md., and will be co-marketed by Philadelphia-based GlaxoSmithKline.

More information

To learn more about lupus, visit the Lupus Foundation of America.

TUESDAY, March 1 (HealthDay News) -- Roflumilast has been approved by the U.S. Food and Drug Administration to treat flares of chronic obstructive pulmonary disease (COPD) involving chronic bronchitis.

The lung disease leads to labored breathing, and is characterized by chronic cough and excessive phlegm. A flare may last for weeks and puts patients at increased risk of death, the FDA said. Cigarette smoking is the leading cause of COPD.

Roflumilast is marketed as Daliresp by New York City-based Forest Laboratories.

Roflumilast blocks an enzyme called phosphodiesterase type 4. The drug is not intended to treat another form of COPD, primary emphysema, the FDA said.

The medication's safety and effectiveness were evaluated in clinical studies involving more than 1,500 people, 40 and older, who had a worsening of chronic bronchitis during the prior year. Roflumilast was approved with a guide that informs users of potential serious side effects, including changes in mood, thinking or behavior, and unexpected weight loss, the agency said.

The most common adverse reactions were diarrhea, nausea, headache, insomnia, back pain, loss of appetite and dizziness. Roflumilast shouldn't be used to treat sudden breathing problems, and isn't recommended for people younger than 18.

More information

The U.S. National Heart Lung and Blood Institute has more about COPD.

MONDAY, Feb. 28 (HealthDay News) -- Edarbi (azilsartan medoxomil) has been approved by the U.S. Food and Drug Administration to treat adults with high blood pressure (hypertension).

Clinical trials showed Edarbi was more effective in lowering high blood pressure over 24 hours than two previously FDA-approved drugs, Diovan (valsartan) and Benicar (olmesartan), the agency said in a news release.

Edarbi helps lower blood pressure by blocking the action of the hormone angiotensin II, the FDA said. The most common adverse reaction was diarrhea, maker Takeda Pharmaceutical North America said in a statement.

Edarbi has a boxed label warning that it shouldn't be used by women who are pregnant. If a woman becomes pregnant while taking the drug, it should be discontinued as soon as possible, the FDA stressed.

Takeda is based in Deerfield, Ill.

More information

The U.S. National Heart Lung and Blood Institute has more about high blood pressure.

THURSDAY, Feb. 17 (HealthDay News) -- Corifact has been approved by the U.S. Food and Drug Administration to treat congenital Factor XIII deficiency, a rare genetic disorder that could cause life-threatening bleeding.

People born with the disorder do not make enough Factor XIII, a clotting ingredient found in most people's blood, the FDA said in a news release. The condition may cause soft-tissue bruising, fatal bleeding inside the head, and in newborns, umbilical cord bleeding.

Corifact was approved as an orphan drug that's intended to treat a rare condition or disease. The FDA said it sanctioned the drug based on a study involving 14 people, including children, who had congenital Factor XIII deficiency. Reported side effects included allergic reactions, chills, fever, headache, and an increase in liver enzymes.

The drug is made from the pooled blood plasma of healthy donors. The FDA said people who use Corifact may wind up creating antibodies that make the drug ineffective, and warned doctors against administering doses higher than those listed on the product's label.

Corifact is made by the German pharmaceutical firm CSL Behring.

More information

The FDA has more about this approval.

THURSDAY, Feb. 17 (HealthDay News) -- The Lap-Band gastric banding device has been approved by the U.S. Food and Drug Administration for people who are less obese than previous candidates, device maker Allergan said.

Under the expanded approval, people may now qualify for the stomach-restricting device if they have failed other weight-loss regimens and have a body mass index (BMI) of 30 to 40. Some 37 million Americans have a BMI in that range, along with at least one coexisting condition such as heart disease, type 2 diabetes, high blood pressure or sleep apnea, the company said in a news release.

Previously, the device -- a silicone band placed around the upper stomach -- had been restricted to people with a BMI of at least 35 if they had a related chronic health condition or 40 if they had no such problem, The New York Times reported.

Under the initial approval, a person 5-feet, 6 inches tall with diabetes would have to weigh 216 pounds to be a candidate for the device. Under the new rules, that person would have to weigh 186 pounds, the newspaper said.

Obesity is the second-highest cause of preventable death in the United States, next to smoking, Allergan said. The company is based in Irvine, Calif.

More information

The FDA has more about the Lap-Band device.

FRIDAY, Feb. 11 (HealthDay News) -- A new test to monitor blood levels of a drug used to prevent rejection in kidney transplant patients has been approved by the U.S. Food and Drug Administration.

The Novartis drug Zortress (everolimus) was approved in 2010 to help suppress the immune system and prevent rejection of a transplanted kidney. But if too much of this type of drug -- called an immunosuppressant -- builds up in a patient's blood, it could be toxic, the FDA said in a news release.

The just-approved QMS Everolimus Immunoassay helps doctors monitor blood levels of Zortress, which like other immunosuppressants must be taken by transplant patients for the rest of their lives.

QMS Everolimus is manufactured by Thermofisher, based in Waltham, Mass.

More information

To learn more about this approval, visit the FDA.

FRIDAY, Feb. 11 (HealthDay News) -- The first three-dimensional mammography system has been approved by the U.S. Food and Drug Administration.

The Selenia Dimensions System produces 3-D and 2-D X-ray images of the breast to help doctors in the early detection of breast cancer. With conventional 2-D mammography systems, about 10 percent of patients require additional testing to determine if abnormalities are cancerous, the FDA said in a news release.

Nearly 40 million mammograms are done each year in the United States, the agency said. The U.S. National Cancer Institute recommends the procedure every one to two years for women 40 and older.

In clinical testing of the newly approved system, radiologists showed a 7 percent improvement in the ability to distinguish cancerous and non-cancerous abnormalities, compared with conventional mammography systems, the FDA said.

Noting that the Selenia system exposed women to about double the amount of radiation of a conventional mammogram, the agency said fewer women had to be re-tested with the new system, sparing them exposure to additional radiation.

The Selenia system is produced by Holgoic Inc., based in Bedford, Mass.

More information

The FDA has more about this approval.

TUESDAY, Feb. 8 (HealthDay News) -- The first heart pacemaker designed to be used safely during certain MRI exams has been approved by the U.S. Food and Drug Administration.

A pacemaker produces electrical pulses designed to prevent a slow or irregular heartbeat. An MRI combines a powerful magnetic field, a computer and radio frequency pulses to produce detailed pictures of the body's inner organs and tissues.

Up to now, people with pacemakers have been advised not to have an MRI, which has the potential to interfere with a pacemaker's settings and may cause a pacemaker's wiring to overheat, the FDA said in a news release.

The Revo MRI SureScan Pacing System has a built-in function that's meant to be turned on before a person undergoes an MRI. Even with the newly approved device, however, an MRI can only be used on certain people, on certain parts of the body, and under the supervision of specially trained technicians, the agency said.

Of 211 people implanted with the device who had an MRI during clinical testing, none had MRI-related complications, the FDA said.

The Revo device is produced by Medtronic Inc., based in Mounds View, Minn.

More information

The FDA has more about this approval.

FRIDAY, Feb. 4 (HealthDay News) -- Makena (hydroxyprogesterone caproate) has been approved by the U.S. Food and Drug Administration to help prevent birth before 37 weeks of pregnancy in women who have had at least one prior early delivery.

Makena, however, is not intended for women who are at greater-than-average risk for preterm birth because they are pregnant with multiple fetuses, the agency said Friday in a news release.

The drug was sanctioned under an accelerated-approval program that requires post-marketing studies that provide additional proof of the medication's benefit, the FDA said.

Makena is designed to be injected into the hip once weekly by a health-care provider, beginning at 16 weeks and no later than 21 weeks of pregnancy.

In clinical testing involving 463 women aged 16 to 43, 37 percent of those who took Makena delivered early, compared with 55 percent among those who didn't take the drug, the FDA said.

The most common side effects were injection site reactions, hives, nausea and diarrhea, the FDA said.

Makena is manufactured by Hologic Inc., of Bedford, Mass.

More information

The U.S. Centers for Disease Control and Prevention has more about preterm birth.

TUESDAY, Jan. 25 (HealthDay News) -- Sanofi-Aventis' prescription non-drowsy antihistamine, Allegra (fexofenadine), has been approved by the U.S. Food and Drug Administration for over-the-counter sale, the company said Tuesday.

The drug will be available in its original prescription strengths starting in March for people two years and older, according to a news release from Sanofi and its U.S. consumer division, Chattem Inc. A version that combines Allegra with a decongestant, Allegra-D, will be available at the same time for people 12 and older without a prescription at the pharmacy counter, the companies said.

More than 40 million Americans have indoor or outdoor allergies, the drug makers said.

More information

To learn more about this drug, visit the U.S. National Library of Medicine.

MONDAY, Jan. 24 (HealthDay News) -- Viibryd (vilazodone hydrochloride) tablets have been approved by the U.S. Food and Drug Administration to treat symptoms of major depressive disorder (MDD) in adults.

MDD is diagnosed when daily life is affected by symptoms that may include depressed mood, loss of interest in once-pleasurable activities, significant changes in weight or appetite, and changes in sleep habits. Episodes can occur only once or multiple times throughout a person's lifetime, the FDA said in a news release.

In clinical testing, adverse reactions to Viibryd included diarrhea, nausea, vomiting and insomnia.

Viibryd and all other approved antidepressants have a boxed label warning that they have shown an increased risk of suicidal thinking among children, teens, and young adults aged 18 to 24, the FDA said.

Viibryd is manufactured by PGXHealth, based in New Haven, Conn.

More information

The U.S. National Institute of Mental Health has more about depression.

TUESDAY, Jan. 18 (HealthDay News) -- Natroba (spinosad) Topical Suspension 0.9 percent has been approved by the U.S. Food and Drug Administration to treat head lice in people aged 4 years and older.

Spread primarily by direct contact, head lice are not thought to cause disease, the FDA said in a news release. The parasitic insects feed on human blood, and live on the head, eyebrows and eyelashes.

Natroba is a topical medication designed to be applied to the scalp or hair. It should be used exactly as prescribed, the agency stressed.

In clinical testing, 552 people were given a 10-minute treatment with Natroba, and a second treatment was applied if live lice were observed 10 days later. After 14 days, about 86 percent of users were lice free, compared with 44 percent among study participants who didn't get the drug.

The most common side effects were irritation of the eyes and skin. The product contains benzyl alcohol, and is not recommended for use in children under the age of 4 years, the FDA said. Topically applied products containing benzyl alcohol have been associated with serious reactions in younger children, including death, the agency warned.

More information

To learn more about head lice, visit the U.S. Centers for Disease Control and Prevention.

TUESDAY, Jan. 18 (HealthDay News) -- The antidepressant medication escitalopram (brand name Lexapro) reduced the frequency and severity of hot flashes in older women, according to new research.

Women in the study experienced nearly 10 hot flashes a day at the start of the study, but those were cut to an average of just over five hot flashes a day in women receiving the antidepressant compared to about 6.5 per day in women receiving a placebo.

"Although hormone treatment is the usual treatment for hot flashes, and it is effective, for women who don't want to assume the potential risks of hormone therapy, this is another option," said the study's lead author, Ellen Freeman, a research professor in the department of obstetrics and gynecology at the University of Pennsylvania School of Medicine.

"We found that after eight weeks of treatment with escitalopram, women had many fewer hot flashes a day compared to those on placebo," she added.

Results of the study, funded by the U.S. National Institutes of Health, are published in the Jan. 19 issue of the Journal of the American Medical Association.

Hormone therapy has traditionally been the most common treatment offered to women experiencing hot flashes as part of the menopausal transition. However, when the Women's Health Initiative study reported in 2002 that hormonal therapy had potentially serious risks, many women decided the benefits didn't outweigh the potential hazards. Since that finding, experts have been able to better identify which women might have a greater risk from hormone therapy, and those for whom hormones are a possible option.

"For some appropriate women -- meaning those without contraindications -- the short-term use of estrogen or hormone therapy may still be a viable option. And [for these women] we use the lowest dose for the shortest time possible," explained Dr. Judi Chervenak, a reproductive endocrinologist at Montefiore Medical Center in New York City.

"But, for women for whom hormones aren't an option, or those who don't want to take hormones, SSRIs [antidepressants] and SSRI-like medication are another option," Chervenak said.

Selective serotonin reuptake inhibitors (SSRIs) are approved by the U.S. Food and Drug Administration for the treatment of depression, but doctors sometimes prescribe them for "off-label" (non FDA-approved) uses, such as for treating pain or -- as in the study -- for the relief of hot flashes. SSRIs include drugs such as Celexa, Lexapro, Paxil, Prozac and Zoloft.

A generic version of Lexapro isn't yet available in the United States, according to the FDA. The cost of a month's supply of the drug varies, but a 20-milligram per day dose is approximately $110 for 30 days.

The current trial included 205 women between the ages of 40 and 62 who were either beginning menopause or who had finished the menopause transition in the past year. To be included in the study, the women had to experience at least 28 hot flashes per week that they would classify as bothersome or severe; most women had more than that.

The women were randomly assigned to receive escitalopram (between 10 and 20 milligrams per day) or a placebo for eight weeks.

The researchers found that 55 percent of the women in the escitalopram group reported at least a 50 percent reduction in the frequency of their hot flashes, compared to 36 percent of those in the placebo group. The escitalopram group also reported a decrease in hot flash severity.

Within three weeks of stopping the medication, women in the escitalopram group had an increase of about 1.5 more hot flashes a day than those in the placebo group, the investigators noted.

Side effects were minimal, said Freeman. Just 4 percent of the escitalopram group dropped out due to adverse side effects.

Exactly how escitalopram helps relieve hot flashes isn't known, according to Freeman. And, she noted, the exact cause of hot flashes still isn't clear.

"Hot flashes are so distressing to so many women that to have any potential new option is appreciated. This isn't the be-all, end-all treatment, but it's another option that we have to offer patients with hot flashes," said Chervenak.

She added that for women who don't wish to take medication, one of the best ways to reduce hot flashes is to keep a symptom diary to see if you can figure out what might be causing your hot flashes so you can avoid it. For example, she said, many women experience a hot flash after drinking red wine. Other potential triggers include caffeine, chocolate, spicy foods and stressful situations.

More information

Learn more about the symptoms of menopause, including hot flashes, and what treatments are available from WomensHealth.gov.

MONDAY, Jan. 10 (HealthDay News) -- Fentanyl (Abstral) tablets have been approved by the U.S. Food and Drug Administration to help opioid-tolerant adults with cancer manage so-called "breakthrough" pain that occurs suddenly and requires a short-term higher dose of a patient's round-the-clock opioid regimen.

Only doctors skilled in the use of Schedule II opioids should prescribe this product, the FDA said in a news release. Any pharmacy, distributor or health-care professional involved in Abstral's distribution or use will have to enroll in a Risk Evaluation and Mitigation Strategy (REMS) program, designed to minimize misuse and abuse, the agency added.

Abstral's safety was evaluated in clinical studies involving 311 opioid-tolerant cancer patients with breakthrough pain. The most common side effects included nausea, constipation, drowsiness and headache.

The FDA warned that the risk of death had been cited in studies of similar immediate-release fentanyl products. "The deaths occurred as a result of improper patient selection and/or improper dosing," the agency said.

Abstral is produced by ProStraken Inc., based in Bedminster, N.J.

More information

To learn more about fentanyl, visit the U.S. National Institute on Drug Abuse.

WEDNESDAY, Dec. 22 (HealthDay News) -- U.S. Food and Drug Administration approval of Gardasil (human papillomavirus vaccine) has been widened to include prevention of anal cancer and associated precancerous lesions, the agency said Wednesday in a news release.

Human papillomavirus (HPV) is associated with about 90 percent of the estimated 5,300 cases of anal cancer diagnosed in the United States each year, the FDA said, citing statistics from the American Cancer Society. More women are diagnosed than men.

The latest approval for Gardasil covers people aged 9 to 26. The vaccine was previously approved for the same age group to prevent cervical, vulvar and vaginal cancers in females, and for genital warts among both sexes.

Gardasil won't prevent development of anal precancerous lesions already present at the time of vaccination, the FDA said.

The most common adverse reactions to the vaccine include fainting, injection-site pain, headache, nausea and fever.

More information

To learn more about anal cancer, visit the U.S. National Cancer Institute.

TUESDAY, Dec. 21 (HealthDay News) -- Medtronic's Endurant AAA Stent Graft system, designed to treat a bulge in the largest abdominal blood vessel, has been approved by the U.S. Food and Drug Administration, the company said Tuesday.

An aneurysm is a bulging portion of a blood vessel that threatens to rupture. Some 1.2 million people have an abdominal aortic aneurysm, which typically causes no symptoms, Medtronic said in a news release. About 70 percent to 90 percent of such patients die if the aneurysm ruptures, the company added.

The newly approved device is a flexible wire frame sewn into a fabric tube. It's implanted in the weakened portion of the aorta, reducing pressure on the aneurysm and diminishing the risk of rupture.

The device is delivered via catheters that are inserted in blood vessels in the groin, Medtronic said.

More information

The U.S. National Library of Medicine has more about this condition.

FRIDAY, Dec. 17 (HealthDay News) -- Medtronic's Arctic Front Cardiac CryoAblation Catheter system has been approved by the U.S. Food and Drug Administration to treat atrial fibrillation, the company said in a news release.

Atrial fibrillation, an erratic heartbeat, is the most common heart rhythm disorder in the United States, affecting some 3 million people, the company said. Medtronic also noted that about 40 percent don't have symptoms and may be under-diagnosed.

The newly approved device isolates the pulmonary vein, the source of errant electrical signals that cause the problem, Medtronic said. The device delivers a coolant via an inflated balloon that freezes tissue and stops the conduction of atrial fibrillation.

Clinical studies showed that about 70 percent of people treated with the Arctic Front system no longer had atrial fibrillation after one year, compared with 7.3 percent of patients treated only with drug therapy, the company said.

More information

To learn more about atrial fibrillation, visit the U.S. National Heart Lung and Blood Institute.

TUESDAY, Dec. 14 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new once-daily dose for Prezista (darunavir), combined with ritonavir to treat people infected with HIV-1, a strain of the virus that causes AIDS.

In a news release, drug maker Tibotec Therapeutics said the approval was meant for adults who hadn't shown resistance to darunavir, the drug's active ingredient.

People with chronic liver disease including hepatitis or cirrhosis should be carefully monitored while taking Prezista, the company said. They also should be watched for signs of a severe skin reaction, which could include severe rash accompanied by fever, fatigue, muscle or joint pain, or blisters.

Prezista does not "cure" HIV-1 or AIDS, and will not prevent transmitting the infection to others, the drug maker stressed.

More information

To learn more about antiviral drugs used to treat HIV infection, visit the FDA.

WEDNESDAY, Nov. 24 (HealthDay News) -- Axiron has been approved by the U.S. Food and Drug Administration as the first topical testosterone solution to be applied to the underarm, makers Eli Lilly and Acrux said in a news release.

Previously approved forms of testosterone replacement therapy have included tablets, skin patches, injections and topical gels. As many as 13 million men aged 45 or older in the United States have symptoms of low testosterone, including decreased sexual desire, fatigue, depressed mood and osteoporosis, the companies said.

Adverse reactions reported during clinical testing of Axiron included skin reactions, increased red blood cell count, headache, diarrhea, vomiting and an increase in blood levels of Prostate Specific Antigen, a screening marker for prostate cancer.

Axiron hasn't been studied in males younger than 18, the drug makers said.

The hormone can be transferred to others via close contact. Unexpected signs of puberty have been reported among young children accidentally exposed to testosterone. Axiom users should immediately cover the applied area and wash their hands to help avoid this possibility, the companies said.

More information

To learn more about testosterone replacement therapy, visit the U.S. National Institute on Aging.

FRIDAY, Nov. 19 (HealthDay News) -- Xgeva (denosumab) has been approved by the U.S. Food and Drug Administration to prevent fractures and other skeletal complications in people with advanced cancer that has metastasized (spread) to the bones.

As many as 75 percent of people with advanced cancer of the prostate, lung or breast have it spread to the bones, Xgeva's manufacturer, Amgen Inc., said in a news release. This may lead to complications such as debilitating pain, bone fractures and compression of the spinal cord, the drug maker said.

Xgeva, injected once monthly, targets a cancer-related protein that destroys bone cells, the FDA said in a news release. The drug's safety and effectiveness were evaluated in clinical studies involving 5,723 people. The trials showed Xgeva was superior to, or at least as effective, as an older drug designed to reduce bone complications from cancer, Zometa (zoledronic acid).

Side effects of Xgeva included lower blood calcium levels, and osteonecrosis of the jaw, a severe disease resulting from reduced blood flow to the jaw, the FDA said.

In June, the drug was first approved under a different name, Prolia, to treat postmenopausal women at high risk of osteoporotic bone fractures.

Amgen is based in Thousand Oaks, Calif.

More information

To learn more about this approval, visit the FDA.

MONDAY, Nov. 15 (HealthDay News) -- Halaven (eribulin mesylate) has been approved by the U.S. Food and Drug Administration to treat metastatic (spreading) breast cancer among people who have had at least two prior chemotherapy treatments for late-stage disease.

In a news release published Monday, the agency said breast cancer is the second-leading cancer cause of death of among women, citing statistics from the National Cancer Institute. Some 207,090 women are expected to be diagnosed with breast cancer this year, resulting in 39,840 deaths, the FDA said.

Halaven, derived from a sea sponge, is believed to work by inhibiting cancer cell growth. Its safety and effectiveness were evaluated in clinical studies involving 762 women with metastatic breast cancer who had had at least two prior chemotherapies for late-stage disease. Median survival was 13.1 months among those who took Halaven, compared to 10.6 months among those who didn't get the drug, the agency said.

The most common adverse reactions were a decrease in white blood cells, anemia, hair loss, fatigue, nausea, nerve damage and constipation.

Halaven is marketed by Eisai Inc, based in Woodcliff Lakes, N.J.

More information

The FDA has more about this approval.

MONDAY, Nov. 15 (HealthDay News) -- Vyvanse (lisdexamfetamine dimesylate) capsules have been approved by the U.S. Food and Drug Administration to treat attention deficit hyperactivity disorder (ADHD) among adolescents aged 13 to 17, maker Shire Pharmaceuticals said Monday.

The FDA previously approved the drug for ADHD in adults and children aged 6 years to 12 years, the British company said in a news release.

Vyvanse was evaluated in clinical trials involving 314 adolescents with ADHD. The most frequently reported side effects were decreased appetite, insomnia and weight loss. Results in adolescents were consistent with earlier findings in adults and children, Shire said.

Vyvanse is a controlled substance and should not be taken by people with heart disease, hardening of the arteries, moderate-to-severe high blood pressure, overactive thyroid, glaucoma, a history of drug abuse, or with a known sensitivity to stimulant medications, the company said.

More information

To learn more about ADHD, visit the U.S. Centers for Disease Control and Prevention.

THURSDAY, Nov. 11 (HealthDay News) -- Egrifta (tesamorelin) has been approved by the U.S. Food and Drug Administration to treat fat deposits caused by HIV-related lipodystrophy. The condition may cause fat deposits around the liver, stomach, and other abdominal organs.

This type of lipodystrophy is believed associated with the antiretroviral drugs used to treat HIV, the virus that causes AIDS, the agency said in a news release.

Egrifta's safety and effectiveness were studied in two clinical trials involving 816 men and women infected with HIV. Participants also had lipodystrophy and excess abdominal fat. Those who received Egrifta had a greater reduction in abdominal fat deposits as measured by CT scan, compared with those who took a non-medicinal placebo.

The effects of the once-daily injected drug on cardiovascular disease haven't been evaluated, the FDA said.

The most common adverse reactions were joint pain, injection site redness and rash, stomach pain, and muscle pain. More participants who took Egrifta had worsening blood sugar levels than those who didn't take the drug, the agency said.

Egrifta is marketed in the United States by EMD Serono, based in Rockland, Mass.

More information

To learn more about this approval, visit the FDA.

FRIDAY, Nov. 5 (HealthDay News) -- The combination drug Kombiglyze (saxagliptin, metformin XR) has been approved by the U.S. Food and Drug Administration to help control blood sugar in adults with type 2 diabetes, makers AstraZeneca and Bristol-Myers Squibb said Friday.

Kombiglyze XR combines a DPP-4 inhibitor called saxagliptin (brand name: Onglyza) with a popular biguanide called metformin XR, the companies said in a news release.

The combination drug has a boxed label warning for lactic acidosis, a rare but serious complication caused by accumulation of metformin, the drug makers said.

Approval of the combined active ingredients in Kombiglyze XR was based on clinical studies involving more than 2,000 adults with type 2 diabetes. The most common adverse reactions were diarrhea and nausea/vomiting.

More information

To learn more about type 2 diabetes, visit the American Diabetes Association.

FRIDAY, Nov. 5 (HealthDay News) -- Cymbalta (duloxetine hydrochloride) has received expanded approval from the U.S. Food and Drug Administration to treat chronic musculoskeletal pain, stemming from conditions including lower back pain and osteoarthritis.

Since its approval as an antidepressant in 2004, some 30 million people in the United States have used the drug, the agency said in a news release. The FDA also has sanctioned Cymbalta for the treatment of diabetic pain, generalized anxiety disorder and fibromyalgia.

The most common side effects from Cymbalta use include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. More serious adverse reactions have included liver damage, allergic reaction, pneumonia, depressed mood, and suicidal thoughts and behavior, the agency said.

The FDA has also warned that Cymbalta should never be used in patients who have recently taken a type of antidepressant called an MAOI, or Mellaril (thioridazine), or who have uncontrolled glaucoma.

Cymbalta is produced by Eli Lilly and Co., based in Indianapolis.

More information

The U.S. National Library of Medicine has more about this drug.

THURSDAY, Nov. 4 (HealthDay News) -- Ofirmev has been approved by the U.S. Food and Drug Administration to treat fever and mild-to-moderate pain, maker Cadence Pharmaceuticals said in a news release.

It's the first FDA-approved injected version of acetaminophen, the San Diego company said. Acetaminophen is the active ingredient in Tylenol.

Approval followed clinical studies involving 1,020 adults and 355 pediatric patients aged 2 and older. The drug's effectiveness to treat pain and fever hasn't been studied in children younger than 2, Cadence said.

The most common side effects of Ofirmev included nausea, vomiting, headache, insomnia, constipation and agitation. The drug shouldn't be used by people with active liver disease, alcoholism or a known sensitivity to acetaminophen, the company said.

More information

To learn more about acetaminophen, visit the FDA.

MONDAY, Nov. 1 (HealthDay News) -- The injected antibiotic Teflaro (ceftaroline fosamil) has been approved by the U.S. Food and Drug Administration to treat bacterial infections including community acquired bacterial pneumonia and methicillin-resistant Staphylococcus aureus (MRSA), the agency said in a news release.

MRSA, resistant to a host of common antibiotics, is typically acquired in hospitals and other health care settings.

Teflaro is among a class of antibiotics called cephalosporins, which treat infections by interfering with the bacterial cell wall.

In clinical testing, the most common side effects of Teflaro included diarrhea, nausea and rash. The drug shouldn't be used by people with a known history of allergy or sensitivity to cephalosporins, the FDA said.

More information

The FDA has more about this approval.

MONDAY, Nov. 1 (HealthDay News) -- Afinitor (everolimus) has received expanded approval from the U.S. Food and Drug Administration to treat subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis, a rare genetic disorder.

The disorder causes non-cancerous tumors on the brain and other parts of the body, including the eyes, lungs, liver, heart, skin and kidneys. It can be fatal if the brain tumors lead to complications, the FDA said in a news release. Symptoms may include learning disabilities, seizures, and lung and kidney disease.

Afinitor was first approved in March 2009 to treat kidney cancer among people in whom standard therapies had failed.

In clinical studies of people with this disorder, the most common side effects of Afinitor included infections of the upper respiratory tract, sinuses and ears, as well as mouth sores and fever.

Afinitor is marketed by Novartis, based in East Hanover, N.J.

More information

To learn more about this approval, visit the FDA.

THURSDAY, Oct. 28 (HealthDay News) -- Lurasidone HCI (Latuda) tablets have been approved by the U.S. Food and Drug Administration to treat adult schizophrenia, which affects about 1 percent of the nation's adult population in a given year, the agency said Thursday in a news release.

The disorder's primary symptoms include hallucinations, delusions, disordered behavior and suspiciousness, the agency said. Among the most common hallucinations is hearing voices that other people don't hear.

Latuda is an atypical antipsychotic drug. All medications in this class contain a boxed label warning that prescribing them for unapproved use in people with dementia-related psychosis increases the risk of death. No atypical antipsychotic drug is sanctioned for people with dementia-related psychosis, the agency warned.

Latuda was approved based on four six-week clinical studies of adults with schizophrenia. Common adverse reactions included drowsiness, restlessness, nausea, an uncontrolled urge to move (akathisia), and movement disorders including tremors, muscle stiffness and slow movement.

Latuda is produced by Sunovion Pharmaceuticals, based in Fort Lee, N.J.

More information

The U.S. National Institute of Mental Health has more about schizophrenia.

THURSDAY, Oct. 28 (HealthDay News) -- Sprycel (dasatinib) has received an additional approval from the U.S. Food and Drug Administration to treat a rare form of blood cancer called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP -CML), the agency said Thursday in a news release.

CML is a slowly progressive disease of the blood and bone marrow that's believed related to a genetic abnormality, the FDA said.

Sprycel is among a class of drugs called oral kinase inhibitors, which are thought to inhibit certain proteins that foster growth of cancer cells. The drug was first approved in 2006 to treat other forms of CML that are resistant to standard therapies, including the Novartis anti-cancer drug Gleevec.

Sprycel's side effects could include decreased bone marrow activity, fluid retention, diarrhea, headache, muscle and bone pain, and rash.

Sprycel's maker, New York City-based Bristol-Myers Squibb, is required as a condition of approval to conduct ongoing clinical studies of the drug's long-term effectiveness for this condition, the FDA said.

More information

To learn more about CML, visit the U.S. National Library of Medicine.

WEDNESDAY, Oct. 20 (HealthDay News) -- Pradaxa (dabigatran etexilate) has been approved by the U.S. Food and Drug Administration to help prevent stroke in people with a type of abnormal heart rhythm called atrial fibrillation.

The condition, which occurs when the heart's two upper chambers beat quickly and out of sync, affects more than 2 million Americans, the agency said in a news release.

Pradaxa is an anti-clotting drug that inhibits an enzyme involved in blood clotting. Clinical studies of the drug found that when compared with the popular anticoagulant warfarin, people with atrial fibrillation had fewer strokes on Pradaxa than those on warfarin, the FDA said.

As with other anti-clotting drugs, a potential side effect is life-threatening bleeding, the agency said. Other potential adverse reactions include stomach discomfort or pain, nausea, heartburn and bloating.

Pradaxa is produced in 75 milligram and 150 milligram strengths by Boehringer Ingelheim Pharmaceuticals, based in Ridgefield, Conn.

More information

The American Heart Association has more about atrial fibrillation.

MONDAY, Oct. 18 (HealthDay News) -- Bristol-Myers Squibb said Monday its liver drug Baraclude (entecavir) has received expanded approval from the U.S. Food and Drug Administration to treat chronic hepatitis B in adults with decompensated liver disease, a form of severe liver damage.

Baraclude was first approved in 2005 for adults with compensated liver disease, a less severe form of damage that means the liver still functions properly, the drug maker said in a news release.

Decompensated liver disease, by contrast, refers to failure of the liver to maintain adequate function, commonly due to severe scarring. Chronic hepatitis B often causes chronic liver inflammation, which can lead to decompensated liver disease, the drug maker said.

About 1.25 million Americans are infected with chronic hepatitis B, Bristol said.

More information

The U.S. National Digestive Diseases Information Clearinghouse has more about hepatitis B.

MONDAY, Oct. 18 (HealthDay News) -- Botox (onabotulinumtoxinA) injection has been approved by the U.S. Food and Drug Administration to prevent chronic migraines among people who get the painful headaches more than 14 days per month.

Botox, made from a purified form of botulinum toxin, has long been approved as a cosmetic wrinkle remover. The drug is administered as multiple injections near the head and neck about once every three months to treat chronic migraines, the agency said in a news release.

Botox hasn't been proven to treat migraines that occur 14 or fewer days per month, and patients should discuss with a physician the appropriateness of the drug for their headaches, the agency said.

Common adverse reactions to Botox used for this purpose include neck pain and headache, the FDA said.

The drug carries a boxed warning that the botulinum toxin could travel from the injection site and cause dangerous symptoms that mimic those of botulism food poisoning, including difficulty swallowing and breathing.

Botox is manufactured by Allergan Inc, based in Irvine, Calif.

More information

To learn more about migraines, visit the U.S. National Library of Medicine.

WEDNESDAY, Oct. 13 (HealthDay News) -- Vivitrol (naltrexone extended release) has been approved by the U.S. Food and Drug Administration to treat and prevent relapse among opioid-dependent people who have completed a detoxification program.

The drug blocks brain receptors for opioids, which include morphine and heroin. In 2006, Vivitrol was approved to treat dependence on alcohol, the agency said in a news release.

There must be no opioids in a patient's system when treatment with Vivitrol is begun, or a user may develop symptoms of opioid withdrawal. And those who begin re-using opioids once treatment with Vivitrol is started risk opioid overdose, the FDA warned.

Treatment with once-monthly Vivitrol should be administered only by a physician using specially provided needles, the agency said. Potential side effects include nausea, fatigue, headache, dizziness, nausea, loss of appetite, painful joints and muscle cramps.

Vivitrol is manufactured by Alkermes Inc.

More information

The U.S. National Library of Medicine has more about drug abuse.

WEDNESDAY, Sept. 22 (HealthDay News) -- Gilenya (fingolimod) has been approved by the U.S. Food and Drug Administration to reduce relapses and delay disability progression in people with relapsing forms of multiple sclerosis.

The drug is among a new class of medications designed to block certain blood cells in lymph nodes, delaying the cells' travel to the brain and spinal cord, the agency said in a news release.

Multiple sclerosis (MS) is a chronic, disabling nervous system disease that affects some 400,000 people in the United States and 2.1 million globally, the FDA said. Symptoms can range from mild limb numbness to severe problems such as paralysis or impaired vision.

Gilenya could have serious side effects including a decrease in heart rate shortly after the drug is started, the FDA said. Other adverse reactions could include a greater risk of infection, and macular edema of the eye. Patients who take the drug should be carefully monitored for these conditions.

The drug's most frequently reported side effects include headache, flu, diarrhea, back pain, cough and elevated enzymes of the liver, the agency said.

Gilenya is made by Novartis, based in Basel, Switzerland.

More information

To learn more about MS, visit the U.S. National Institute of Neurological Disorders and Stroke.

FRIDAY, Sept. 17 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new use for three cardiac resychronization therapy defibrillators (CRT-D) to treat people with a heart abnormality called left bundle branch block who also have mild cases of heart failure or heart failure with no symptoms.

The devices are all made by Boston Scientific Corp. As CRT-D devices, they combine the ability to shock an abnormally beating heart back to its normal rhythm, and the ability to improve coordination of the heart's left and right ventricles as they pump blood through the body.

In people with left bundle branch block, activation of the left ventricle is delayed, causing it to beat out of step with the heart's right ventricle.

In a news release, the FDA said the new approval was based on results from an 1,820-person, three-year study that found among people with left bundle branch block, the CRT-D devices reduced the risk of death by 57 percent, compared to those fitted with a standard implanted defibrillator.

CRT-Ds are to be used in addition to heart failure drug therapy, not as a replacement for it, the agency warned.

As a condition of approval, the FDA said it is requiring Boston Scientific to conduct two long-term studies of the devices.

More information

The FDA has more about this approval.

FRIDAY, Sept. 10 (HealthDay News) -- A treatment for poisoning from pesticides and similar chemicals has been approved by the U.S. Food and Drug Administration for use in children, nearly 50 years after it was first approved for adults.

Pralidoxime chloride (Protopam Chloride) was approved by the FDA in 1964 as an antidote to pesticides and other chemicals in the organophosphate class. The injected antidote slows the attachment of the poisonous chemical to a person's nerve endings, the agency said in a news release.

The FDA acknowledged the drug already has been used "for many years" as an emergency antidote in children, and that approving it for pediatric use would "give health-care professionals better guidance on how to use this drug safely and effectively."

Organophosphates are commonly used at farms and by licensed exterminators, the agency said. Symptoms of ingestion could include mild reactions such as runny nose, teary eyes or vomiting, to more serious symptoms including trouble breathing and convulsions.

Adverse reactions to the antidote itself could include blurred vision, dizziness, headache, fatigue, nausea, difficulty breathing and increased heart rate or blood pressure, the agency said.

Protopam Chloride is produced by Baxter Healthcare, based in Deerfield, Ill.

More information

The U.S. Centers for Disease Control and Prevention has more about organophosphate poisoning.

MONDAY, Aug. 16 (HealthDay News) -- The ella emergency contraceptive has been approved by the U.S. Food and Drug Administration. It's been available in Europe for more than a year under the brand name ellaOne.

To be taken within five days of contraceptive failure or unprotected intercourse, the drug is not meant to be used as a routine contraceptive, the FDA said in news release. Among a class of drugs called progesterone agonists/antagonists, it's intended to inhibit or delay ovulation.

Ella's safety and effectiveness were demonstrated in studies conducted in the United States, United Kingdom and Ireland, the agency said. The most common side effects included headache, nausea, abdominal pain, menstrual pain, fatigue and dizziness.

Women with known or suspected pregnancy or those who are breast-feeding shouldn't use ella, the FDA said.

The drug is distributed by Watson Pharma Inc., based in Morristown, N.J.

More information

The FDA has more about this approval.

FRIDAY, July 30 (HealthDay News) -- The annual flu vaccine for the 2010-2011 influenza season has been approved by the U.S. Food and Drug Administration, the agency said Friday.

The yearly vaccine protects against the three strains predicted to be most prevalent in the United States. This year's shot includes protection against the H1N1 ("swine") flu that emerged in 2009. The specific strains are:

• A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus)
• A/Perth /16/2009 (H3N2)-like virus
• B/Brisbane/60/2008-like virus

Brand names and manufacturers for the vaccine are: Afluria, CSL Limited; Agriflu, Novartis Vaccines and Diagnostics; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist, MedImmune Vaccines Inc.; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone and Fluzone High-Dose, Sanofi Pasteur Inc.

"The best way to protect yourself and your family against influenza is to get vaccinated every year," said Karen Midthun, M.D., acting director of FDA's Center for Biologics Evaluation and Research. "The availability of a new seasonal influenza vaccine each year is an important tool in the prevention of influenza related illnesses and death."

More information

The FDA has more about this approval.

THURSDAY, July 29 (HealthDay News) -- Cuvposa (glycopyrrolate) Oral Solution has been approved by the U.S. Food and Drug Administration to treat chronic drooling in children aged 3 to 16.

Neuromuscular problems among the developmentally disabled is a prime cause of chronic drooling in this age group, the agency said in news release. The drug is designed to reduce the amount of saliva produced.

Glycopyrrolate has been FDA-sanctioned for years for people with peptic ulcers and to lower the amount of saliva produced among people under anesthesia. It had often been prescribed to reduce chronic drooling as a so-called "off-label" use. This term is used when a doctor legally prescribes a drug for a different reason that its FDA-approved drug label recommends.

Previously, off-label use of glycopyrrolate meant that tablets had to be crushed to allow drooling children to ingest the medication. Cuvposa is flavored liquid that makes it easier to swallow at an optimal dose, the agency said.

Common side effects of the medication are dry mouth, constipation and retention of urine.

Cuvposa is marketed by Shionogi Pharma Inc., based in Osaka, Japan.

More information

To learn more about this approval, visit the FDA.

MONDAY, July 26 (HealthDay News) -- Tribenzor, a three-in-one drug to treat high blood pressure, has been approved by the U.S. Food and Drug Administration.

Tribenzor combines amlodipine, marketed by Pfizer as Norvasc, olmesartan medoxomil, marketed by Daiichi Sankyo as Benicar, and a third drug, hydrochlorothiazide. The combination medication was approved for people whose high blood pressure isn't well controlled on other combinations of anti-hypertension drugs.

Daiichi Sankyo, based in Japan with U.S. headquarters in Parsippany, N.J., produces the newly approved drug.

In a news release, the company said adverse reactions to once-daily Tribenzor could include dizziness, swelling, headache, fatigue, muscle spasms, nausea, diarrhea or infections of the respiratory or urinary tracts.

More information

To learn more about high blood pressure, visit the U.S. National Heart Lung and Blood Institute.

FRIDAY, July 23 (HealthDay News) -- The first generic version of enoxaparin sodium injection (brand name: Lovenox), a blood-thinning drug designed to prevent deep vein thrombosis, has been approved by the U.S. Food and Drug Administration.

The condition, abbreviated as DVT, can cause potentially deadly blood clots that form in veins deep within the body. Veins in the lower leg and thigh are most prone to the condition, the agency said in a news release. DVT-related clots have the potential to break away and travel to the lung, triggering a deadly blockage in a lung artery called a pulmonary embolism.

About 100,000 cases of pulmonary embolism are reported each year in the United States, and it's the third-most common cause of death among people in the hospital, the FDA said.

Lovenox, FDA-approved in 1993, is made from the blood-thinning drug heparin. The makers of generic drugs that earn the agency's approval must demonstrate that the generics contain the same active ingredients as the brand-name medications.

As with the brand-name drug, generic Lovenox will include a boxed warning that patients who take the drug and are undergoing certain spinal procedures are at increased risk of bleeding or bruising that could cause long-term or permanent paralysis.

License to produce the generic version of the drug was granted to Sandoz Inc., based in Broomfield, Colo.

More information

The U.S. National Library of Medicine has more information about this drug.

TUESDAY, July 6 (HealthDay News) -- A tiny telescope that's implanted in an eye affected by advanced age-related macular degeneration (AMD) has been approved by the U.S. Food and Drug Administration.

The Implantable Miniature Telescope replaces the natural lens and magnifies an image more than two times, the FDA said in a news release.

The device is meant for people aged 75 and older who have blind spots associated with end-stage AMD. Candidates will be trained with an external telescopic device to see if they may benefit from the implanted product, the agency said.

AMD damages the eye's macula, causing vision loss in the center of the visual field. The condition affects mostly older people, often making it impossible to recognize faces or perform tasks such as watching television, the FDA said. Some 8 million Americans have been diagnosed with the condition, and about 25 percent of those are significantly visually impaired.

The FDA said it's requiring the labeling to warn that the device puts users at greater risk of injury to the eye's cornea.

As a condition of approval, California-based VisionCare Ophthalmic Technologies will conduct two follow-up studies of the device, the agency said.

More information

To learn more about AMD, visit the U.S. National Eye Institute.

TUESDAY, June 29 (HealthDay News) -- The first generic version of Effexor extended release capsules (venlafaxine hydrochloride) to treat major depressive disorder has been approved by the U.S. Food and Drug Administration.

Prescribing information for the generic version of Effexor XR may differ from that of the brand name drug because of various patents held by the brand name drug's maker, Wyeth Pharmaceuticals, the FDA said in a news release. But the same safety warnings will apply.

The generic version will be manufactured by Teva Pharmaceuticals, based in Wales, Penn.

The drug's label includes a warning that antidepressants may raise the risk of suicidal thoughts or tendencies among some children, teens and young adults, the agency said.

More information

To learn more about this drug, visit the U.S. National Library of Medicine.

FRIDAY, June 25 (HealthDay News) -- The OraQuick HCV Rapid Antibody Test to detect antibodies from the hepatitis C virus has been approved by the U.S. Food and Drug Administration.

The blood diagnostic is a test strip that does not require an additional device to obtain results in about 20 minutes, the agency said in a news release.

HCV is commonly transmitted through shared use of an intravenous drug needle or from an infected mother to her child. Initially it can cause inflammation of the liver and may progress to liver disease or liver cancer.

Some 3.2 million people in the United States are chronically infected with the virus, and some 17,000 new infections are reported each year, government statistics show.

The OraQuick test is produced by OraSure Technologies, based in Bethlehem, Penn.

More information

The FDA has more about this approval.

THURSDAY, June 24 (HealthDay News) -- Merck & Co.'s Dulera inhaler has been approved for people 12 and older whose asthma isn't controlled with other medication, the company said Thursday in a news release.

Dulera combines a corticosteroid (mometasone furoate) and a long-acting beta agonist (formoterol fumarate). The latter class of drug increases the risk of asthma-related hospitalization in children and teens, Merck said, so Dulera should only be used by people whose asthma isn't adequately controlled with a different class of drug.

FDA approval of Dulera was based on clinical testing of 12-to-26 weeks among 1,509 people aged 12 and older. The most common adverse reactions included sinus inflammation (sinusitis) and headache.

Dulera isn't a rescue medication and does not replace a fast-acting inhaler to treat symptoms that begin suddenly, Merck said.

More information

The FDA has more about this drug's history.

MONDAY, June 21 (HealthDay News) -- Abbott's Architect HIV Ag/Ab Combo assay has been approved by the U.S. Food and Drug Administration.

Traditional HIV diagnostics have detected HIV antibodies, which are developed days after an infection as a sign that the body is working to fight the invading virus. The Architect assay also detects the HIV p24 antigen, which is a protein produced by the virus immediately after infection, Abbott said in a news release.

The risk of HIV transmission is highest just after infection with the AIDS-causing virus, the company said.

Since the new test could detect HIV infection days earlier than antibody-only diagnostics, people could be alerted before unknowingly spreading the infection and be treated earlier, Abbott said.

Some 56,000 new cases of HIV infection are diagnosed each year in the United States, the Illinois-based company said, citing the U.S. Centers for Disease Control and Prevention.

More information

To learn more about HIV / AIDS, visit AIDS.gov.

FRIDAY, June 18 (HealthDay News) -- The anti-cancer drug Tasigna (nilotinib) has received new approval from the U.S. Food and Drug Administration to include people in the early stages of a rare blood cancer called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+CP-CML), the agency said in a news release.

The disease, linked to a genetic abnormality, progresses slowly and affects the blood and bone marrow. Tasigna is thought to block a signal that causes leukemic cells to develop. The drug was approved in October 2007 for people in the disease's later stages.

Users of Tasigna, however, are at greater risk of an abnormal heart rhythm disorder called QT prolongation. The FDA said earlier this year it sanctioned an updated medication guide and other strategies to inform patients and doctors of the drug's risks.

The most common side effects reported during clinical testing include: itching, headache, nausea, fatigue and muscle pain. Serious adverse reactions affecting the blood could include a decrease in bone marrow activity, low blood platelets, anemia and a decrease in infection-fighting white blood cells, the agency said.

Tasigna is marketed by Novartis Pharmaceuticals, based in East Hanover, N.J.

More information

To learn more about this drug's approval history, visit the FDA.

THURSDAY, June 17 (HealthDay News) -- The chemotherapy drug Jevtana (cabazitaxel) has been approved by the U.S. Food and Drug Administration to treat advanced prostate cancer that worsens despite use of a standard drug therapy, docetaxel.

In some cases of prostate cancer, the male hormone testosterone spurs tumor growth. To block production of this hormone, doctors may prescribe drugs, surgery or other hormones. Despite testosterone suppression, some prostate cancers continue to worsen, prompting the need for different treatments such as the newly approved drug.

Jevtana, approved to be used in combination with the steroid prednisone, was given an expedited six-month review, the FDA said in a news release. The drug was evaluated in a single study involving 755 men. Average survival for those who received a drug regimen that included Jevtana was 15.1 months, compared with 12.7 months among those who received a different regimen, the agency said.

Commonly reported side effects among those who used Jevtana included a decrease in white blood cells, a reduction in blood platelets, diarrhea, fatigue, nausea, vomiting, constipation, weakness and renal failure.

Jevtana is marketed by Sanofi-Aventis, based in Bridgewater, N.J.

More information

The FDA has more about this drug's approval history.

WEDNESDAY, June 2 (HealthDay News) -- The injected drug Prolia (denosumab) has been approved by the U.S. Food and Drug Administration to treat post-menopausal women at high risk of bone fracture due to osteoporosis.

Prolia is administered approximately once every six months to increase bone strength and mass, and to prevent bone destruction, the FDA said in a news release.

The drug was evaluated in clinical trials involving more than 7,800 women aged 60 to 91. About 80 percent of people with osteoporosis are women, and about half of women aged 50 or older will sustain an osteoporosis-related fracture at some point in their lives, U.S. government statistics indicate.

Common reported side effects of Prolia include back and extremity pain, high cholesterol, and bladder infection. Severe reactions may include low blood calcium and skin reactions, the agency said.

Because the drug suppresses bone turnover, additional severe reactions could include osteonecrosis of the jaw, a severe bone disease. Prolia will be distributed with a medication guide that explains these and other risks to patients, the FDA said.

Prolia is manufactured by Amgen Inc., based in Thousand Oaks, Calif.

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To learn more about this approval, visit the FDA.

TUESDAY, May 25 (HealthDay News) -- Lumizyme (alglucosidase alfa) has been approved by the U.S. Food and Drug Administration to treat late-onset Pompe disease, a genetic disorder that often leads to fatal respiratory failure.

Pompe, affecting one in every 40,000 to 300,000 births, is caused by a gene mutation that prevents the body from making enough of an essential enzyme. This leads to heart and skeletal muscle weakness that commonly progresses to respiratory failure.

Lumizyme is thought to replace the deficient enzyme, acid alpha-glucosidase (GAA), the FDA said in a news release. The approval sanctions the drug for people aged 8 and older with non-infantile (late-onset) Pompe disease.

The drug will carry a boxed label warning of potential side effects including anaphylaxis and severe allergic reactions, the FDA said. Other commonly reported side effects include hives, diarrhea, vomiting, shortness of breath, itchy skin or rash, neck pain, partial hearing loss, flushing, extremity pain and chest discomfort.

Lumizyme will be made available through a restricted distribution system "to ensure that it is used by the correct patient group," the agency said.

The drug is produced by Genzyme, based in Cambridge, Mass.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about Pompe Disease.

MONDAY, May 24 (HealthDay News) -- The Simplexa diagnostic test to detect infection with the H1N1 "swine" flu virus has been approved by the U.S. Food and Drug Administration, the agency said Monday in a news release.

Prior to the approval, the test was available under the agency's Emergency Use Authorization, which allows the FDA to sanction use of unapproved medical products during a public health emergency. The agency declared such an emergency on April 26, 2009, and the new approval permits the test's continued use after the emergency declaration expires.

The test uses nasal specimens to detect the presence of the H1N1 virus, although it does not indicate the infection's severity.

The first wave of H1N1 hit the United States in the spring of 2009, followed by a second wave last fall. As many as 88 million people were infected in the United States through March 13, the FDA said.

The Simplexa test is produced by Focus Diagnostics Inc., of Cypress, Calif.

More information

The U.S. Centers for Disease Control and Prevention has more about H1N1 flu.

MONDAY, May 17 (HealthDay News) -- Roxro Pharma's Sprix (ketorolac tromethamine) nasal spray has been approved by the U.S. Food and Drug Administration for the short-term treatment of moderate to moderately severe pain, the manufacturer said Monday in a news release.

The nasal spray contains the non-steroidal anti-inflammatory drug (NSAID) ketorolac. The non-narcotic medication minimizes the chances for abuse and eliminates side effects associated with narcotic pain relievers, the drug maker said.

The drug should not be used for longer than five days. Potential side effects may include peptic ulcers or gastrointestinal bleeding, and the drug shouldn't be used in people who already have these conditions, a high risk of bleeding, or advanced renal failure, the company said.

Roxro is based in Menlo Park, Calif.

More information

The U.S. National Library of Medicine has more about pain relievers.

THURSDAY, May 6 (HealthDay News) -- The Bayer Healthcare Pharmaceuticals combination hormonal contraceptive Natazia has been approved by the U.S. Food and Drug Administration.

The tablet combines two female hormones, estrogen and progestin, and is meant to deliver doses four times during its 28-day treatment cycle, the FDA said in a news release.

The drug was evaluated by more than 1,800 women during clinical testing in North America and Europe. The most common adverse effects were irregular bleeding, breast tenderness, headache, nausea and vomiting, weight gain and acne.

Women who smoke while taking the drug are at greater risk of serious cardiovascular problems. Women older than 35 who smoke should not use the product, the agency warned.

Bayer is based in Wayne, N.J.

More information

The FDA has more about this approval.

MONDAY, May 3 (HealthDay News) -- A new test that spots a deadly blood-borne parasite in donated blood, tissue or organs has been approved by the U.S. Food and Drug Administration.

Trypanosoma cruzi (T. cruzi) is a parasite that causes Chagas disease, which can be fatal, the agency said in a news release. Some 300,000 people in the United States are believed infected with the parasite.

Chagas disease usually is spread by insects that feed on human blood. It also can be transmitted during blood transfusion, organ or tissue transplant, or between pregnant mother and unborn child, the FDA said.

The newly approved diagnostic, the Abbott Prism Chagas, is produced by Illinois-based Abbott Laboratories.

More information

To learn more about Chagas disease, visit the U.S. National Library of Medicine.

THURSDAY, April 29 (HealthDay News) -- Provenge (sipuleucel-T), a therapy designed to boost the immune system's ability to combat prostate cancer, has been approved by the U.S. Food and Drug Administration.

The therapy is produced by obtaining the person's own immune cells, exposing them to a protein found in most forms of prostate cancer, then returning them to the donor. The therapy is administered three times, each approximately two weeks apart, the agency said in a news release.

Provenge has been approved for men with no symptoms or minimal symptoms of the disease, which has spread to other parts of the body and is resistant to standard hormone therapy.

In a study of 512 men, men who took Provenge had average survival of 25.8 months, compared with 21.7 months among those who didn't get the treatment, the FDA said.

Almost all recipients of Provenge had an adverse reaction, most commonly chills, fatigue, fever, back pain, nausea, joint pain or headache. About 25 percent of recipients suffered more serious side effects, including stroke or a serious reaction to the injection, the agency said.

Behind skin cancer, prostate cancer is the second most common cancer affecting men in the United States. Last year, 192,000 cases were diagnosed and some 27,000 men died from the disease, the FDA said, citing U.S. National Cancer Institute statistics.

Provenge is produced by Seattle-based Dendreon Corp.

More information

To learn more about prostate cancer, visit the National Cancer Institute.

WEDNESDAY, April 28 (HealthDay News) -- The first device that uses radiofrequency energy to help control lung inflammation in adults with severe chronic asthma has been approved by the U.S. Food and Drug Administration.

The Alair Bronchial Thermoplasty System is designed for people 18 and older whose asthma isn't controlled with medication, including inhaled corticosteroids or long-acting beta agonists.

The device delivers radiofrequency energy directly to the airways, heating and reducing the thickness of lung tissue and improving users' ability to breathe, the agency said in a news release.

To achieve the device's full benefit, users will require multiple sessions targeting different parts of the lungs.

The device was evaluated in a clinical study involving 297 people with severe and persistent asthma. As a condition of approval, California-based manufacturer Asthmatx Inc. must conduct additional studies to evaluate the product's long-term safety and effectiveness, the FDA said.

Potential side effects include asthma attacks, wheezing, chest pain or tightness, partially collapsed lung, coughing up blood, anxiety, headache or nausea.

The device should not be used by people with an implanted pacemaker or defibrillator, the agency said.

More information

The FDA has more about this approval.

TUESDAY, April 13 (HealthDay News) -- Pancreaze delayed release capsules have been approved by the U.S. Food and Drug Administration for the estimated 200,000 or more people in the United States whose bodies do not produce enough pancreatic enzymes, the agency said in a news release.

People who may need this product have conditions including cystic fibrosis, chronic inflammation of the pancreas, pancreatic tumors, or removal of all or part of the pancreas.

Unapproved pancreatic enzyme products have been available "for many years," the agency conceded. It reminded makers that by April 28, they must stop producing and distributing unapproved versions of these products. The FDA said it first announced the decision to rid the U.S. market of these unapproved products in October 2007.

The agency said it is working with Johnson and Johnson, which produces Pancreaze, and the makers of two other approved pancreatic enzyme products, to "make the public aware" of the approved products' availability.

Other products approved for this use are the Abbott Products' Creon and Eurand Pharmaceuticals' Zenpep.

More information

The FDA has more about this approval.

THURSDAY, April 8 (HealthDay News) -- The first generic versions of two drugs to treat high blood pressure, Cozaar (losartan potassium) and Hyzaar (losartan potassium and hydrochlorothiazide), have been approved by the U.S. Food and Drug Administration.

The generic versions will carry the same label warnings that they should not be used by pregnant women during their second or third trimesters, the agency said in a news release.

The brand-name versions of both drugs are manufactured by Merck & Co. Licenses to produce generics of one or both medications were granted to a number of firms, including Teva Pharmaceuticals, Mylan Pharmaceuticals, Roxane Laboratories and Torrent Pharmaceuticals, the FDA said.

More information

The FDA has more about generic drugs.

TUESDAY, April 6 (HealthDay News) -- A reformulated version of the often-abused painkiller OxyContin has been approved by the U.S. Food and Drug Administration, the agency said in a news release.

OxyContin contains the powerful opioid oxycodone. Since it's designed to be released slowly, each tablet contains "a large quantity" of the drug, allowing users to take fewer tablets less often, the agency said. The new formulation is designed to prevent tablets from being cut, broken, chewed or dissolved.

About 500,000 people used OxyContin for non-medical reasons for the first time in 2008, the FDA said, citing statistics from the U.S. Substance Abuse and Mental Health Services Administration.

The drug's manufacturer, Connecticut-based Purdue Pharma, is required as a condition of approval to study whether the new formulation reduces abuse.

More information

The U.S. Drug Enforcement Administration has more about OxyContin abuse.

MONDAY, April 5 (HealthDay News) -- The TachoSil sealant patch has been approved by the U.S. Food and Drug Administration to prevent bleeding from small blood vessels in certain cardiovascular surgery cases, the agency said Monday.

The product is comprised of a collagen sponge, produced from horse tendons, that is coated with two proteins, fibrinogen and thrombin. The proteins trigger a series of chemical reactions that produce fibrin, a stringy protein that fosters production of a blood clot.

The biodegradable patch is designed to break down inside the body within six months. Plasma used in the product's manufacture is screened for blood-borne diseases, the FDA said, and the collagen taken from horse tendons is filtered from impurities, including viruses that affect horses.

In clinical testing involving 119 people, 74.6 percent of patch users stopped bleeding within three minutes, compared with 33.3 percent among those who didn't get the patch. Possible side effects include allergic reactions, the FDA said.

The product is manufactured by Nycomed Austria.

More information

The FDA has more about this approval.

WEDNESDAY, March 31 (HealthDay News) -- Polidocanol (Asclera) has been approved by the U.S. Food and Drug Administration to treat small varicose veins, the agency said in a news release.

Varicose veins are swollen or twisted blood vessels that most often form in the legs. They are more likely to develop in pregnant women, obese people and those who must stand for long periods. Advancing age and family history also may make them more likely to form, the FDA said.

Asclera is sanctioned to improve the appearance of varicose veins that are 1 millimeter or less in diameter. The most frequent reactions to the drug reported during clinical testing included blood pooling from affected veins, bruising, irritation, discoloration and injection-site pain.

The drug is distributed by Wisconsin-based BioForm Medical Inc., and is produced by the German firm Chemische Fabrik Kreussler & Co.

More information

To learn more about varicose veins, visit the U.S. National Library of Medicine.

FRIDAY, March 26 (HealthDay News) -- Zyclara topical cream (imiquimod 3.75 percent) has been approved by the U.S. Food and Drug Administration to treat actinic keratoses (AKs), a precancerous condition that's commonly found on skin frequently exposed to the sun.

AKs -- sometimes confused with eczema or psoriasis -- are small, red patches of skin that also may be scaly or rough, drug maker Graceway Pharmaceuticals said. They are most often found on the face, bald scalp, hands, shoulders and arms. Some 10 million Americans have the condition, which tends to recur, the company said in a news release.

AKs should be treated without delay, since they may progress to a form of skin cancer called squamous cell carcinoma. In clinical testing involving people with five to 20 AKs on the face or scalp, Zyclara reduced the total number of AKs by 82 percent, the news release said.

The most common side effects reported were local skin reactions with redness, scabbing or crusting, and sores or ulcers.

More information

To learn more about actinic keratoses, visit the Skin Cancer Foundation.

THURSDAY, March 25 (HealthDay News) -- Xifaxan (rifaximin) has been approved for people with advanced liver disease to reduce the risk of overt hepatic encephalopathy (HE), a reduction in brain function that occurs among people whose livers can't remove poisons from the blood, the U.S. Food and Drug Administration said in a news release.

HE is thought to occur from a buildup of ammonia, which Xifaxan works to reduce, the agency said. The drug is already FDA-approved to treat traveler's diarrhea.

Xifaxan's effectiveness in preventing HE was evaluated in clinical trials in the United States, Canada and Russia. People who took the drug were less likely to develop the disorder, compared to those who took an inactive placebo.

Common reported side effects of the drug included swelling of the arms and legs, nausea, gas and headache.

Xifaxan is produced by North Carolina-based Salix Pharmaceuticals.

More information

The FDA has more about this drug's approval history.

THURSDAY, March 18 (HealthDay News) -- The drug Carbaglu (carglumic acid) has been approved by the U.S. Food and Drug Administration to treat a rare genetic disorder called N-acetylglutamate synthase (NAGS deficiency), which results in elevated blood levels of ammonia, the agency said Thursday.

The drug's safety and effectiveness were evaluated in 23 people with NAGS. Carbaglu reduced blood ammonia within a day and lowered levels to a normal range within three days, the FDA said.

The most common side effects included vomiting, abdominal pain, fever, inflamed tonsils, anemia, ear infection, diarrhea, nasal and throat inflammation, and headache.

The drug should only be administered by a doctor with experience in treating metabolic problems, the agency said. The medication is manufactured by Orphan Europe.

More information

To learn more about NAGS deficiency, visit Orphan Europe.

WEDNESDAY, March 17 (HealthDay News) -- The Esteem implanted hearing system is the first completely implanted system approved by the U.S. Food and Drug Administration for adults with moderate-to-severe sensorineural hearing loss, a permanent lack of hearing, the agency said Wednesday.

Sensorineural hearing loss can be caused by genetic factors or by inner-ear damage resulting from causes such as loud noise, a viral infection or general aging, the FDA said in a news release.

Three implanted components comprise the system: a sound processor, a sensor and a driver that converts electrical signals transmitted by the sound processor to the inner ear, which perceives them as sounds.

The most severe adverse reactions resulted from the implant surgery, and included facial paralysis (7 percent) and taste disturbance (42 percent). Most of these reactions resolved during the one-year clinical testing of the device, the agency said.

The device is produced by Minnesota-based Envoy Medical Corp. As a condition of approval, Envoy must conduct longer-term studies of the device's safety and effectiveness, the FDA said.

More information

To learn more about hearing loss, visit the U.S. National Library of Medicine.

FRIDAY, March 12 (HealthDay News) -- Boston Scientific's Express LD Iliac Stent has been approved by the U.S. Food and Drug Administration to treat iliac artery disease, the company said in a news release.

A stent is a hollow tube that props open a blood vessel that's been blocked by a buildup of sticky plaque. In this case, the iliac arteries are located in the pelvis and supply blood to the legs. When they become clogged, it can lead to poor blood flow, leg pain and other complications.

Iliac artery disease can be treated with medication, surgery or a process called angioplasty, which involves expanding a balloon-like device inside a clogged artery to improve blood flow. Installing the stent is a less invasive option than surgery, Boston Scientific said.

More information

The U.S. National Library of Medicine has more about this topic.

TUESDAY, March 9 (HealthDay News) -- Botox (onabotulinumtoxin A) has been approved by the U.S. Food and Drug Administration to treat spasms (spasticity) in the flexor muscles of the elbow, wrist and fingers in adults who have had a stroke, the agency said Tuesday in a news release.

Spasticity is a common aftereffect of stroke, and can make performing daily activities difficult.

Botox temporarily stops the connection between nerves and muscles, ending spasms in affected muscles, the agency said. Adverse reactions to Botox may include nausea, fatigue, bronchitis, muscle weakness and limb pain.

Botox has a boxed label warning that because the drug is produced from the same bacterium that causes botulism, the toxic substance has the potential to spread beyond the intended area and cause symptoms similar to those of botulism. These may include life-threatening problems with breathing and swallowing.

Botox hasn't been proven effective in treating similar problems in other upper-limb muscles, the agency warned, and isn't meant to substitute for physical therapy.

The drug is produced by California-based Allergan Inc.

More information

To learn more about this drug, visit the U.S. National Library of Medicine.

THURSDAY, March 4 (HealthDay News) -- Kapidex (dexlansoprazole) has been given the new name Dexilant -- so approved by the U.S. Food and Drug Administration -- to avoid confusion with other drugs that have similar names.

There is no problem with Kapidex itself and, other than the name switch, nothing else will be changed about the drug, the FDA said. It's a proton pump inhibitor, used to treat heartburn and other conditions caused by excess stomach acid.

In a news release, the FDA cited pharmacy errors in dispensing Kapidex, approved in January 2009, citing confusion with the drugs Casodex and Kadian. All three drugs have widely different uses; Casodex is prescribed for prostate cancer and Kadian to treat pain.

The newly named heartburn drug will begin appearing on store shelves in late April, the FDA said. It's manufactured by Takeda Pharmaceuticals North America.

More information

The FDA has more about this drug's approval history.

TUESDAY, March 2 (HealthDay News) -- The first generic version of Flomax (tamsulosin hydrochloride) capsules has been approved by the U.S. Food and Drug Administration to treat benign prostatic hyperplasia (BPH), the medical term for an enlarged prostate.

California-based IMPAX Laboratories will be producing the generic version, which will have the same prescribing information and safety warnings as the brand-name capsules, the FDA said in a news release.

BPH affects more than half of men in their 60s and as many as 90 percent of men older than 70, the agency said. Common symptoms include weak urine stream, urgency, leaking or dribbling, and more frequent urination -- often at night.

More information

To learn more about enlarged prostate, visit the U.S. National Kidney and Urologic Diseases Information Clearinghouse.

FRIDAY, Feb. 26 (HealthDay News) -- Velaglucerase alfa for injection (VPRIV) has been approved by the U.S. Food and Drug Administration to treat a rare inherited disorder called Gaucher disease, the agency said Friday.

The disorder is caused by lack of an enzyme called glucocerebrosidase. This allows a fatty substance called a lipid to build up in the liver, spleen, bones, bone marrow and nervous system. The disorder affects only about 1 in 50,000 people, the FDA said in a news release.

The newly approved treatment replaces the lacking enzyme in people with Type 1 Gaucher disease, the disorder's most common form. An older form of replacement therapy is in short supply, the agency said.

VPRIV's safety and effectiveness were evaluated in clinical trials involving 82 people aged 4 and older with Type 1 Gaucher. The most common side effects reported were allergic reactions; dizziness; pain in the abdomen, joints and back; nausea, fatigue, fever, and prolonged blood clotting.

VPRIV is produced by Massachusetts-based Shire Human Genetic Therapies Inc.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about this disorder.

WEDNESDAY, Feb. 24 (HealthDay News) -- The Prevnar 13 vaccine, a combination shot that protects children aged 6 weeks through 5 years from a host of illnesses, including pneumonia and ear infections, has been approved by the U.S. Food and Drug Administration.

The vaccine, a successor to a decade-old combination shot known as Prevnar, prevents illness caused by 13 different classes of Stretococcus pneumoniae, which could also cause infections of the blood and covering of the brain and spinal cord, the FDA said in a news release. The earlier shot targeted six fewer types of the bacterium.

Prevnar 13 is meant to be given in a four-dose schedule at 2, 4, 6 and 12-15 months of age, the FDA said.

The new vaccine was evaluated in a clinical study of 5,084 infants and youngsters who received Prevnar 13, compared with 2,760 who got the earlier version of Prevnar. Side effects were similar with both vaccines, including pain, injection-site swelling and redness, irritability, loss of appetite and fever.

Prevnar 13 is produced by Pennsylvania-based Wyeth Pharmaceuticals, a unit of Pfizer Inc.

More information

The FDA has more about this approval.

WEDNESDAY, Feb. 24 (HealthDay News) -- Mirapex ER (pramipexole dihydrochloride extended-release) has been approved by the U.S. Food and Drug Administration as a once-daily option to treat early Parkinson's disease, drug maker Boehringer Ingelheim said in a news release.

Mirapex was first approved more than a decade ago. Approval of the extended-release form was based on a clinical study of more than 400 people with early Parkinson's who were assessed after nine weeks and 18 weeks.

The safety, tolerability and adverse effects of the extended-release form were similar to those of original Mirapex, the company said. The most frequently reported side effects included nausea, dizziness, sleepiness, insomnia, weakness and constipation.

Parkinson's is a chronic, progressive and often debilitating neurological disease affecting close to 1 million people in the United States, the drug maker said. One person is diagnosed with Parkinson's every nine minutes.

More information

The FDA has more information about this drug's approval history.

MONDAY, Feb. 22 (HealthDay News) -- The Novartis vaccine Menveo has been approved to prevent bacterial meningitis and other health problems caused by meningococcal disease, the drug maker said in a news release.

Meningitis is an inflammation of the membrane that surrounds the brain and spinal cord. Infection with meningococcal bacteria -- which also may trigger a deadly blood infection called sepsis -- affects more than 500,000 people each year, resulting in some 50,000 deaths worldwide, Novartis said. As many as 3,000 cases of meningococcal disease per year are diagnosed in the United States.

Even with early treatment, bacterial meningitis and related conditions may progress quickly and may kill within 48 hours of when symptoms begin, the company said. About one in five survivors has permanent side effects, which may include limb amputations, seizures, paralysis, hearing loss and learning disabilities.

Menveo (groups A, C, Y and W-135 conjugate vaccine) is based on the same technology as the company's Menjugate meningococcal vaccine, approved outside the United States since 2000, Novartis said.

More information

The U.S. National Library of Medicine has more about meningitis.

FRIDAY, Feb. 19 (HealthDay News) -- Rituxan (rituximab) has been approved by the U.S. Food and Drug Administration to treat a slowly progressing form of blood and bone marrow cancer known as chronic lymphocytic leukemia (CLL), the agency said in a press release.

The disease mostly affects people 50 and older. It's diagnosed in some 16,000 people each year, causing about 4,400 deaths, the FDA said.

Rituxan binds to the surface of cancer cells, making it easier for the immune system to attack the cancer. The drug was approved for people with CLL who are starting chemotherapy and for those who haven't responded to other anti-cancer drugs. It's administered with two other chemotherapy medications, fludarabine and cyclophosphamide.

In a study of 817 people who hadn't been treated previously with chemotherapy, survival without progression of cancer was eight months longer among those given Rituxan and chemotherapy that among those who had chemotherapy alone, the FDA said.

The drug's label, however, carries a "boxed warning" of increased risk of an infusion reaction -- resembling an allergic reaction -- which could cause symptoms including hives, fever, nausea, chills and low blood pressure, the agency said.

The warning also mentions potential adverse reactions including skin sores or rashes, an often-fatal brain infection called progressive multifocal leukoencephalopathy (PML), and a syndrome that could damage the kidneys that's caused when rapidly-dying cancer cells release toxins into the bloodstream.

Rituxan is produced by San Francisco-based Genentech, a unit of Roche Group.

More information

The FDA has more about this approval.

THURSDAY, Feb. 11 (HealthDay News) -- Olmesartan medoxomil (Benicar), approved in 2002 to treat high blood pressure in adults, has been sanctioned by the U.S. Food and Drug Administration to treat the same condition in children aged 6 to 16, drug maker Daiichi Sankyo said Thursday.

Some 3.6 million children in the United States have high blood pressure, a number that's risen in tandem with children's weight, the company said in a news release. Obese children are three times more likely to have hypertension than non-obese kids, the firm added.

Benicar blocks the actions of a hormone called angiotensin II to increase blood pressure.

Adverse reactions reported among children taking Benicar were similar to those of adults, including dizziness, Daiichi said.

More information

To learn more about high blood pressure in children, visit the American Heart Association.

TUESDAY, Feb. 9 (HealthDay News) -- U.S. Food and Drug Administration approval for Crestor (rosuvastatin) has been widened to include people who have no obvious symptoms of heart disease, Dow Jones reported.

Maker AstraZeneca can now market the drug to people with normal or slightly above-normal levels of cholesterol, a group formerly considered at low risk for cardiovascular disease, the news service said.

Crestor was deemed effective in the company-sponsored "Jupiter" trial involving nearly 18,000 people with normal or near-normal cholesterol but elevated levels of C-reactive protein (CRP), a marker of bodily inflammation.

Elevated CRP may predict development of cardiovascular disease, the news service said.

Crestor and other statin drugs were designed to lower LDL, often referred to as "bad" cholesterol, which can lead to the buildup of fatty deposits in the arteries and pose an increased risk of heart attack and stroke.

Among participants in the Jupiter trial, people with normal or near-normal cholesterol who took Crestor for an average of 1.9 years showed a 44 percent reduction in heart attack, stroke and other cardiovascular problems, compared with those who took a placebo, the Dow Jones report said. The results were so overwhelming that the trial was halted early.

In December, an FDA-sanctioned panel of experts voted 12 to 4 to recommend approval of Crestor for people without cardiovascular disease.

More information

The U.S. National Library of Medicine has more about this drug.

WEDNESDAY, Feb. 3 (HealthDay News) -- Collagenase clostridium histolyticum (Xiaflex) has been approved by the U.S. Food and Drug Administration as the first drug to treat a disabling hand condition called Dupuytren's contracture.

The condition, affecting connective issue in the hand's palm, can affect someone's ability to straighten and use their fingers.

The disorder is most common in white people and in men aged 50 and older, the agency said in a news release.

Xiaflex is a biologic product that's designed to break down the excessive collagen in the hand that characterizes the disorder.

The drug is injected directly into the hand. Because it may cause tendon rupture if improperly used, Xiaflex should only be delivered by an experienced health professional, the FDA warned.

The most common reported adverse reactions to the drug are fluid buildup, swelling, bleeding and injection site-pain. A serious allergic reaction also is possible, the agency said, although none had been observed during clinical testing.

Xiaflex is produced by Pennsylvania-based Auxilium Pharmaceuticals.

More information

To learn more about this approval, visit the U.S. Food and Drug Administration.

MONDAY, Feb. 1 (HealthDay News) -- The U.S. Food and Drug Administration has expanded approval for Tykerb (lapatinib) to include postmenopausal women with hormone- and HER2-positive advanced breast cancer who require hormone therapy.

The new approval is for Tykerb's use in combination with a second anti-cancer drug, Femara (letrozole), the agency said in a news release.

In women with HER2-positive breast cancer, those who received Tykerb and Femara more than doubled the time they lived without progression of their cancer, compared with those who received Femara alone (35 weeks versus 13 weeks), the FDA said.

Tykerb, first approved in 2007, is designed to block signals that tumor cells need to grow.

The drug is produced by GlaxoSmithKline.

More information

The FDA has more about this approval.

TUESDAY, Jan. 26 (HealthDay News) -- Victoza (liraglutide) has been approved to treat type 2 diabetes in some adults, the U.S. Food and Drug Administration said in a news release.

But the agency warned that the once-daily injection shouldn't be used as an initial (first-line) treatment until additional studies are completed, since the drug may cause thyroid tumors or a rare disease called medullary thyroid cancer. People at risk for this type of cancer shouldn't use the drug, the FDA stressed.

Victoza, among a class of medicines called glucagon-like peptide-1 (GLP-1) receptor agonists, is meant to be used along with diet and exercise to control blood sugar by helping the pancreas make more insulin after a person eats.

In clinical studies involving more than 3,900 patients, people who took Victoza had more cases of pancreatic inflammation (pancreatitis) than people who took other diabetes drugs, the FDA said. The drug should be stopped if severe abdominal pain develops or tests confirm pancreatitis, the agency said.

Victoza is produced by Denmark-based Novo Nordisk.

More information

To learn more about this approval, visit the FDA.

TUESDAY, Jan. 26 (HealthDay News) -- Morphine Sulfate Oral Solution has been approved by the U.S. Food and Drug Administration to treat acute and chronic pain. Sanctioned doses are 100 milligrams per 5 mL and 20 milligrams per 1 mL, the agency said in a news release.

Although the drug has been prescribed for this use "for many years," the agency said, this form and concentration hadn't been approved until now.

The painkiller was sanctioned as part of the agency's unapproved drug initiative to "make sure marketed drugs meet current FDA standards," the news release said.

The drug is manufactured by Ohio-based Roxane Laboratories, a unit of Boehringer Ingelheim.

More information

To learn more about morphine sulfate, visit the U.S. National Institutes of Health.

MONDAY, Jan. 25 (HealthDay News) -- The first "percutanous" heart valve to be implanted via a tube in a leg vein and guided up to the heart has been approved by the U.S. Food and Drug Administration.

In a news release, the agency said the Medtronic Melody Transcatheter Plumonary Valve and Ensemble Delivery System could delay the need for open heart surgery to replace a previously implanted valve "conduit" that has stopped functioning properly.

A conduit is implanted to treat a leak or other defect, present at birth, of the heart's pulmonary valve, which helps regulate the system that carries blood from the heart's right ventricle to the lungs.

The Melody system doesn't "cure" the heart condition, and like a conduit, can wear out over time and require replacement, the FDA said. But the Melody can allow a conduit to continue functioning, delaying the need for open heart surgery. This can especially benefit a child born with the heart condition who would otherwise face additional surgeries during his or her lifetime.

The FDA said it is requiring Medtronic to conduct post-approval studies to assess the product's long-term risks and benefits.

More information

To learn more about heart valve disease, visit the U.S. National Heart, Lung, and Blood Institute.

FRIDAY, Jan. 22 (HealthDay News) -- Dalfampridine (Ampyra) extended-release tablets have been approved by the U.S. Food and Drug Administration to help adults with multiple sclerosis (MS) who have trouble walking.

In clinical testing, people who took Ampyra had faster walking speeds that those who took a placebo, the agency said in a news release.

MS is a chronic, often disabling disease affecting the brain, spinal cord and optic nerves. Some 400,000 people in the United States and 2.5 million globally have been diagnosed with the disease, the FDA said.

The drug, if given at doses higher than the recommended 10 milligrams twice daily, can cause seizures, the agency warned. The most common reported side effects include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, nasal or throat swelling, irregularity, indigestion and burning or itchy skin.

People with moderate-to-severe kidney disease shouldn't take Ampyra, the FDA said.

The drug is marketed in the United States by Hawthorne, N.Y.-based Acorda Therapeutics.

More information

The FDA has more about this approval.

WEDNESDAY, Jan. 20 (HealthDay News) -- A device that helps the heart's left ventricle pump blood in people who have severe heart failure but who aren't candidates for heart transplant has been approved by the U.S. Food and Drug Administration.

The HeartMate II is already FDA-approved for people awaiting heart transplant and other "complex" forms of treatment, the agency said in a news release.

The heart-assist device is a small mechanical pump that's surgically implanted just below the heart. A cable that powers the pump passes through the user's skin to a controller that's worn around the wrist. A physician has the ability to program the pump's speed, based on the user's needs, the FDA said.

As a condition of approval, the California-based device maker, Thoratec Corp., will conduct an additional clinical study to further evaluate the device's performance, the agency said.

More information

The FDA has more about devices that help the heart beat.

MONDAY, Jan. 11 (HealthDay News) -- Actemra (tocilizumab) has been approved by the U.S. Food and Drug Administration to treat rheumatoid arthritis among people who haven't responded to, or who cannot tolerate, other approved RA drugs, the agency said Monday.

Actemra was approved for limited use because of adverse reactions noted in clinical trials, including the possibility of elevated liver enzymes, elevated "bad" cholesterol (LDL), hypertension, and gastrointestinal perforations, the agency said in a news release.

Actemra blocks an immune system protein called interleukin-6, which is found in excess in people with rheumatoid arthritis.

As a condition of the approval, San Francisco-based Genentech, the drug's marketer, must conduct additional clinical studies to evaluate the drug's long-term effectiveness and cardiovascular safety, the FDA said.

The agency said it also is requiring development of a Risk Evaluation and Mitigation Strategy for doctors, to inform physicians on how to monitor patients for possible liver or gastrointestinal side effects.

The most common adverse effects found in clinical testing included upper respiratory infections and other "serious" infections, headache, nasal and sinus inflammation, high blood pressure and increased liver enzymes, the agency said.

More information

The FDA has more about this approval.

THURSDAY, Dec. 24 (HealthDay News) -- Fluzone High-Dose, a seasonal flu vaccine for people 65 and older, has been approved by the U.S. Food and Drug Administration, the agency said in a news release.

Seniors are at highest risk for complications of seasonal flu, including hospitalization and death. The Fluzone High-Dose vaccine, designed to prevent infection with influenza subtypes A and B, was given accelerated approval as a product designed to prevent serious or life-threatening disease. As part of the approval, manufacturer Sanofi Pasteur is required to "conduct further studies to verify that [the vaccine] will decrease seasonal influenza after vaccination," the FDA said.

Because of the vaccine's higher potency, mild side effects were reported more frequently compared with Sanofi's standard-strength Fluzone vaccine, the agency said. These included pain, injection-site redness and swelling, headache, muscle ache and fever.

People who are sensitive to egg products or who have had life-threatening reactions to prior flu shots shouldn't be vaccinated with Fluzone High-Dose, the FDA said.

More information

The U.S. Centers for Disease Control and Prevention has more about flu vaccination.

FRIDAY, Dec. 18 (HealthDay News) -- The U.S. Food and Drug Administration has expanded approval for the Spiriva Handihaler (tiotropium bromide inhalation powder) to include reducing symptoms during flares of chronic obstructive pulmonary disease (COPD), makers Boehringer Ingleheim Pharmaceuticals and Pfizer said.

COPD is a broad term for respiratory disorders that include chronic bronchitis and emphysema.

The Spiriva Handihaler, first FDA-approved in 2004, is already sanctioned as a once-daily maintenance treatment for COPD-related problems, including cough, wheezing or difficulty breathing,

COPD leads to the deaths of an estimated 120,000 Americans annually, the drug makers said in a news release.

More information

The U.S. National Heart Lung and Blood Institute has more about COPD.

TUESDAY, Dec. 15 (HealthDay News) --Generic versions of the drug Aricept (donepezil hydrochloride) that will dissolve instantly on the tongue have been approved by the U.S. Food and Drug Administration to treat dementia resulting from Alzheimer's disease, the agency said Tuesday.

The newly approved tablets disintegrate rapidly, making it easier for elderly or disabled people to take them, the FDA said in a news release.

Alzheimer's is a progressive brain disease that slowly destroys memory and thinking, and, eventually, a person's ability to perform simple tasks. It's the most common cause of dementia among older people, although it is "not a normal part of aging," the FDA release said.

The generic versions of Aricept, to be available in 5 milligram and 10 milligram strengths, are to be produced by Philadelphia-based Mutual Pharmaceuticals.

More information

To learn more about this approval, visit the FDA.

MONDAY, Dec. 14 (HealthDay News) -- Zyprexa Relprevv (olanzapine), a long-acting version of the antipsychotic drug Zyprexa, has been approved to treat schizophrenia in adults, maker Eli Lilly said Monday.

The single injection lasts up to four weeks, the drug maker said in a news release. Clinical studies involving 2,054 people found Zyprexa Relprevv effective in managing symptoms of schizophrenia, including hallucinations, delusions, apathy and social withdrawal.

The brain disorder affects about 1.1 percent of the American population, or some 2.4 million people, Lilly said.

Possible adverse reactions could include sedation (including coma) and delirium. Elderly people with dementia-related psychosis are at increased risk of death from the drug and should not take it, the company said.

More information

To learn more about this drug, visit the National Alliance on Mental Illness.

THURSDAY, Dec. 10 (HealthDay News) -- An additive that allows for more efficient storage of blood platelets up to five days has been approved by the U.S. Food and Drug Administration.

Platelets -- the component that helps blood clot -- are commonly used to prevent or treat bleeding, are given to people having chemotherapy to treat cancer, and are administered to people who don't produce their own platelets, the agency said in a news release.

Currently, platelets are stored in a solution made from a component of blood plasma. The newly approved additive, InterSol, will free up some of the donor plasma for other purposes, the FDA said.

InterSol is derived from salt. It's manufactured by Illinois-based Fenwal Inc.

More information

To learn more about blood platelets, visit the University of Oklahoma Health Sciences Center.

THURSDAY, Dec. 3 (HealthDay News) -- Kalbitor (ecallantide) has been approved by the U.S. Food and Drug Administration to treat dangerous flares of sudden fluid buildup in people with hereditary angiodema (HAE), the agency said.

The rare genetic disorder, caused by a defect in a blood protein, can cause rapid swelling of the face and other parts of the body. This dangerous onset can lead to permanent disability, disfigurement or death, the FDA said in a news release.

Some 10,000 people in the United States have HAE. Kalbitor is the second drug approved to treat the disorder. The newly sanctioned medication is approved for people 16 and older.

Since side effects of the injected drug could include a severe allergic reaction known as anaphylaxis, Kalbitor should only be administered by a healthcare professional, the agency said. Other adverse reactions could include headache, nausea, diarrhea, fever or skin irritations.

Kalbitor is marketed by Massachusetts-based Dyax Corp.

More information

To learn more about this approval, visit the FDA.

WEDNESDAY, Dec. 2 (HealthDay News) -- Merck & Co.'s Zegerid OTC (omeprazole/sodium bicarbonate) has been approved by the U.S. Food and Drug Administration to treat frequent heartburn, the company said Wednesday in a news release.

The over-the-counter product, to be available in the first half of next year, contains prescription Zegerid's original formula, Merck said. The 14-day course of treatment is taken once daily to treat frequent heartburn for up to 24 hours.

Zegerid OTC is a proton pump inhibitor (PPI), which works to suppress stomach acid.

Some 50 million adults in the United States have heartburn symptoms more than twice weekly (defined as frequent heartburn), and as many as 25 million have heartburn daily, the company said.

More information

The U.S. National Library of Medicine has more about heartburn.

TUESDAY, Nov. 17 (HealthDay News) -- The Qutenza (capsaicin) skin patch has been approved by the U.S. Food and Drug Administration to treat pain due to postherpetic neuralgia (PHN), the nerve pain that may follow shingles, drug maker NeurogesX said in a news release.

Capsaicin is the substance in chili peppers that provides the heat sensation. The Qutenza 8 percent patch delivers a synthetic form of the substance to the skin where the nerve pain is felt, the company said.

Clinical studies showed PHN pain was reduced for up to 12 weeks with the one-hour application of as many as four Qutenza patches, which can be cut to conform to the areas of pain. The non-narcotic medication is unlikely to cause drowsiness or interact with other drugs, NeurogesX said.

The most common clinical side effects reported were redness at the application site, an increase in blood pressure and itching.

Qutenza is likely to be available in the United States in the first quarter of next year, the company said. NeurogesX is based in San Mateo, Calif.

More information

To learn more about nerve pain, visit the U.S. National Library of Medicine.

MONDAY, Nov. 16 (HealthDay News) -- Tranexamic acid (Lysteda) has been approved by the U.S. Food and Drug Administration as the first non-hormonal drug to treat heavy menstrual bleeding, a medical condition called menorrhagia. It works to stabilize a protein that helps blood clot.

Some 3 million women in the United States report the condition each year, usually with no apparent cause, the FDA said in a news release.

Tranexamic acid has been used since the mid-1980s to reduce or prevent bleeding after tooth extraction in people with hemophilia, a genetic disorder caused by lack of a blood clotting factor.

Common side effects among people using Lysteda include headache, sinus and nasal symptoms, back or abdominal pain, muscle or joint pain, anemia and fatigue.

People who use Lysteda while also taking hormonal contraceptives may run the risk of increased blood clots, stroke or heart attack. So women who take a hormonal contraceptive should only use Lysteda if there is a strong medical need, the FDA stressed.

Lysteda is made by Kentucky-based Xanodyne Pharmaceuticals.

More information

To learn more about heavy menstrual bleeding, visit the U.S. National Library of Medicine.

FRIDAY, Nov. 13 (HealthDay News) -- CSL Limited's H1N1 influenza vaccine has been approved by the U.S. Food and Drug Administration to include children 6 months and older, the agency said. Previously, the shot had been approved only for adults.

The vaccine is subject to the same manufacturing and testing oversight as seasonal flu vaccines, the agency said in a news release. The expanded approval also includes CSL's seasonal flu shots.

"Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of children's vaccines available is an important first step in responding to the H1N1 outbreak," FDA commissioner of food and drugs Margaret Hamburg said in a statement.

As with any vaccine grown in eggs, people allergic to eggs or egg products shouldn't get this vaccine, the FDA said.

Common adverse reactions include pain, redness and swelling at the injection site. Less common side effects may include irritability, loss of appetite and drowsiness.

CSL is based in Australia.

More information

Visit the FDA to learn more about this approval.

FRIDAY, Nov. 6 (HealthDay News) -- The Gloucester Pharmaceuticals drug Istodax (romidepsin) has been approved by the U.S. Food and Drug Administration to treat cutaneous T-cell lymphoma (CTCL) in people who have tried at least one prior systemic therapy, the drug's manufacturer said in a news release.

CTCL is a form of non-Hodgkin's lymphoma, a cancer of the germ-fighting lymphatic system. The cancerous cells of the skin can cause itchy, disfiguring patches, and the cancer may involve other organs including the lymph nodes, blood and viscera, the drug maker said.

Blood parameters should be carefully monitored while people take Istodax, and since it can harm a fetus, the drug shouldn't be taken by pregnant women, Gloucester said. Istodax also may interfere will some contraceptives that contain estrogen, the company warned.

Approval of Istodax followed two clinical studies of 167 patients, Gloucester said. The drug is expected to be available in January.

More information

There's more about this drug's history at the FDA.

TUESDAY, Oct. 27 (HealthDay News) -- Arzerra (ofatumumab) has been approved by the U.S. Food and Drug Administration to treat chronic lymphocytic leukemia (CLL), a cancer of the blood and bone marrow.

The drug, produced by London-based GlaxoSmithKline, is approved when other types of chemotherapy no longer control the disease, the FDA said in a news release.

CLL, a slowly progressing form of leukemia, mostly affects people aged 50 and older. Some 16,000 people annually are diagnosed with the disease, and about 4,400 die, the agency said.

Arzerra binds to white blood cells known as B cells, making it easier for the body's immune system to fight cancerous B cells. The drug was approved under an accelerated process granted to drugs that satisfy unmet medical needs, the FDA said. Ongoing studies will establish whether combining Arzerra with standard forms of chemotherapy delays progression of CLL.

Common side effects recorded during clinical testing of Arzerra included an increased risk of progressive multifocal leukoencephalopathy (PML), an often-fatal brain infection. Also, people with a history of hepatitis should be carefully monitored while taking the drug.

Other side effects may include a decrease in blood cell counts, pneumonia, fever, cough, diarrhea, fatigue and shortness of breath, the FDA said.

More information

The FDA has more about this drug's approval history.

TUESDAY, Oct. 20 (HealthDay News) -- GlaxoSmithKline's seasonal flu vaccine, Fluarix, has been approved by the U.S. Food and Drug Administration for children aged 3 to 17, the agency said in a news release.

The vaccine had been approved for adults 18 and older.

Fluarix contains killed influenza A and B viruses. With the approval, Glaxo is now the fourth company licensed in the United States to produce a vaccine for children against seasonal flu. Fluarix will not protect against the H1N1 swine flu virus, the agency warned.

The vaccine's safety and effectiveness were evaluated in a clinical study of more than 3,300 children that compared Fluarix with Fluzone, an FDA-approved seasonal flu vaccine for children 6 months and older. The two vaccines were about equal in triggering production of blood antibodies that would protect children from seasonal flu, the FDA said.

Common adverse reactions to Fluarix -- including injection-site pain and redness, irritability, loss of appetite and drowsiness -- are typical of many flu shots, the agency said.

More information

Learn more about this approval from the FDA.

TUESDAY, Oct. 20 (HealthDay News) -- Votrient (pazopanib) has been approved to treat advanced renal cell carcinoma, a form of kidney cancer in which cancerous cells invade the lining of small tubes in the kidney called tubules, the U.S. Food and Drug Administration said in a news release.

The oral drug is designed to prevent angiogenesis, the growth of blood vessels that tumors need to survive. Five other drugs have been approved to treat kidney cancer since 2005, the agency said.

This year, some 49,000 people have been diagnosed with renal cell carcinoma and 11,000 have died, the FDA said.

In a 435-person clinical trial, the time before a tumor began re-growing or the patient died averaged 9.2 months for people taking Votrient, compared with 4.2 months among those who didn't take the drug.

Possible adverse reactions to Votrient include diarrhea, high blood pressure, hair color changes, nausea, vomiting, fatigue, abdominal pain and headache. The drug also can be highly toxic to the liver, so people taking Votrient should have their liver function closely monitored, the FDA said. The medication also can cause heart rhythm problems.

Since it can harm a fetus, the drug shouldn't be used by pregnant women, the agency said.

Votrient is produced by the British drug maker GlaxoSmithKline.

More information

The FDA has more about this approval.

MONDAY, Oct. 19 (HealthDay News) -- The U.S. Food and Drug Administration on Friday approved use of the cervical cancer vaccine Gardasil to prevent genital warts caused by human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.

Each year, about two of every 1,000 men in the United States are newly diagnosed with genital warts, the FDA said.

Gardasil currently is approved for use in girls and women ages 9 through 26 to prevent cervical, vulvar and vaginal cancer caused by HPV types 16 and 18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts caused by types 6 and 11, the agency said.

HPV is the most common sexually transmitted infection in the United States and most genital warts are caused by HPV infection.

More information

The FDA has more about this approval.

MONDAY, Oct. 19 (HealthDay News) -- Micardis (telmisartan) has received expanded approval from the U.S. Food and Drug Administration to reduce the risk of heart attack or stroke in people 55 or older who cannot take a class of cardiovascular drugs called ACE inhibitors, maker Boehringer Ingelheim said Monday.

Micardis belongs to its own class called angiotensin II receptor blockers. It's been available in the United States since 1998 to treat high blood pressure.

The FDA also granted new approval for a drug called Twynsta, which combines the active ingredient in Micardis with the calcium channel blocker amlodipine. The combination drug is meant to prevent high blood pressure when used alone, or in tandem with other anti-hypertension drugs, Boehringer said in a news release.

Some studies estimate that as many as 20 percent of people taking ACE inhibitors have side effects, which could prevent the drugs' use as prescribed, the company said. Micardis has possible side effects of its own, including upper respiratory infection, back pain, sinusitis and diarrhea. The drug shouldn't be used by pregnant women, Boehringer said.

More information

To learn more about this drug, visit the U.S. National Library of Medicine.

FRIDAY, Oct. 16 (HealthDay News) -- GlaxoSmithKline's Cervarix vaccine has been approved by the U.S. Food and Drug Administration to prevent the leading cause of cervical cancer, the Associated Press reported Friday.

The British drug maker said it expects the vaccine will be available in U.S. pharmacies later this year. In 2007, the FDA requested additional data from Glaxo, delaying Cervarix's release, the wire service said. The vaccine is available in almost 100 other countries.

Cervarix inhibits human papilloma virus (HPV) strains 16 and 18, which cause 75 percent of cervical cancers, the AP said. Of the more than 100 identified strains of HPV, about 15 are known to cause cervical cancer. HPV, spread mostly through sexual contact, affects some 6 million people in the United States each year, although most cases show no symptoms and resolve on their own.

Cervarix will compete with Merck & Co.'s Gardasil, launched in the United States in 2006, the wire service said.

Clinical side effects of Cervarix include injection-site pain and swelling, fatigue and headache.

More information

The U.S. Centers for Disease Control and Prevention has more about HPV.

MONDAY, Oct. 12 (HealthDay News) -- Berinert (C1-esterase inhibitor) has been approved by the U.S. Food and Drug Administration as the first sanctioned treatment for a rare genetic disease called hereditary angiodema (HAE), the agency said in a news release.

The drug is approved for adults and adolescents who have symptoms of HAE, including painful abdominal attacks and facial swelling. Symptoms may develop for no apparent reason, or during stress, surgery or infection, the FDA said. The drug, a protein derived from human plasma, was deemed safe and effective in a clinical trial of 124 adults and adolescents with HAE.

People with a life-threatening sensitivity to C1 esterase inhibitor preparations shouldn't take Berinert. The most serious adverse reactions reported during clinical testing included an increase in the severity of HAE-associated pain, headache, nausea, muscle spasms, diarrhea and vomiting, the agency said.

Berinert is produced by the German drug maker CSL Behring Inc.

More information

The U.S. National Library of Medicine has more about HAE.

FRIDAY, Sept. 25 (HealthDay News) -- Stelara (ustekinumab) has been approved by the U.S. Food and Drug Administration for adults with moderate-to-severe plaque psoriasis.

The immune system disorder is characterized by the rapid overproduction of skin cells, which leads to red, scaly patches of inflamed skin. Some six million people in the United States have plaque psoriasis, the FDA said in a news release.

Stelara is a laboratory-produced monoclonal antibody that mimics the body's own antibodies. It blocks the action of two proteins that contribute to the overproduction of skin cells, the agency said.

The drug was evaluated in three studies of 2,266 people. Because it reduces the immune system's ability to fight infection, some users have developed serious infections that required hospitalization. Users may also have a heightened risk of cancer, the FDA said.

The agency is requiring the drug's maker, Pennsylvania-based Centocor Ortho Biotech, to devise a risk evaluation and mitigation strategy that includes a communication plan aimed at doctors and patients. The company is a subsidiary of Johnson & Johnson.

More information

To learn more about this approval, visit the FDA.

FRIDAY, Sept. 25 (HealthDay News) -- The drug Folotyn (pralatrexate) has been approved to treat Peripheral T-cell Lymphoma (PTCL), an often aggressive form of non-Hodgkin's lymphoma, the U.S. Food and Drug Administration said Friday.

The drug, given accelerated approval because it treats an unmet medical need, was sanctioned for people whose disease has returned or hasn't responded to other types of chemotherapy, the agency said in a news release.

PTCL strikes fewer than 9,500 people each year in the United States, the FDA said. The disease affects a type of white blood cell, called a T-cell, involved in the body's disease-fighting immune system.

Approval of Folotyn was based on clinical data showing it reduced tumor size in 27 percent of 109 people with PTCL who were studied. The most common adverse reactions included sores of the lips, mouth and digestive tract, low white blood cell counts, fever, nausea and fatigue.

Since the drug can harm a fetus, women taking Folotyn should avoid becoming pregnant, the FDA said. Anyone taking the drug should also take folate and vitamin B12 supplements to help reduce irritation of the mucous membranes.

Folotyn is produced by Colorado-based Allos Therapeutics, which is required to conduct additional studies of tumor shrinkage and life expectancy, the agency said.

More information

The FDA has more about this drug.

FRIDAY, Sept. 11 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new test for women with pelvic tumors that are known to need surgery. The test, called OVA1, will help doctors decide if the tumor probably is ovarian cancer and how to proceed surgically.

OVA1 will identify some women who have negative results from ovarian cancer tests, but whose surgical cases would benefit from a gynecological oncologist's involvement, the agency said in a news release. Gynecological oncologists -- doctors who specialize in women's cancer -- have been found to help improve survival when they perform ovarian cancer surgery, the FDA said.

The new blood test -- approved for women aged 18 and older who have pelvic masses that require surgery -- is not meant to screen for ovarian cancer or replace diagnostics used to detect ovarian cancer, the FDA stressed.

OVA1 is produced by California-based Vermillion Inc., in conjunction with scientists at The Johns Hopkins University in Baltimore.

More information

The FDA has more about this approval.

TUESDAY, Sept. 8 (HealthDay News) -- Metozolv (metoclopramide) has been approved by the U.S. Food and Drug Administration to treat diabetic gastroparesis and gastroesophageal reflux disease (GERD), drug maker Salix Pharmaceuticals said Tuesday.

Diabetic gastroparesis, caused by nerve damage, occurs when the stomach takes too long to empty. It affects up to 5 million people in the United States, and females are at greater risk than males, Salix said in a news release.

GERD, sometimes referred to as heartburn, affects about 100 million people in the United States. Metozolv was approved to treat GERD when other drugs haven't worked, the company said.

The drug was approved for short-term use of four to 12 weeks. Longer-term use may increase risk of developing a movement disorder called tardive dyskinesia, for which there is no known treatment. In some people, the disorder eases or disappears once Metozolv is stopped, Salix said.

Other adverse effects may include headache, nausea, fatigue, and vomiting.

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THURSDAY, Sept. 3 (HealthDay News) -- Intuniv (guanfacine) has been approved by the U.S. Food and Drug Administration to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in people aged 6 to 17, drug maker Shire Plc said Thursday.

The once-daily drug, to be available in 1-to-4 mg. strengths, is expected on pharmacy shelves in November, the company said in a news release. The way it works is unclear, but the drug is thought to directly engage receptors in the brain's prefrontal cortex, an area that has been linked to the disorder.

Intuniv is not a controlled substance and "has no known potential for abuse or dependence," Shire said. It cited statistics from the U.S. Centers for Disease Control and Prevention (CDC) that some 4.4 million children in the United States have been diagnosed with ADHD.

In clinical testing, the most common adverse reactions to Intuniv included tiredness, abdominal pain, dizziness, a drop in blood pressure, dry mouth and constipation, the company said.

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MONDAY, Aug. 31 (HealthDay News) -- The U.S. Food and Drug Administration has approved Valcyte (valganciclovir hydrochloride) to prevent cytomegalovirus (CMV) disease in children 4 months to 16 years who are undergoing kidney or heart transplant, Swiss drug maker Roche said Monday.

CMV disease is a common infection among people who have had an organ transplant. Such patients may be infected with CMV before their surgeries, or be receiving organs that are infected, Roche said in a news release. Children are at increased risk of CMV infection and serious complications when their immune systems are suppressed to prevent rejection of donor organs.

CMV infects about 80 percent of the U.S. population, the company said, and in most cases lies dormant in the body. But when the immune system is weakened, CMV complications could affect the lungs, kidneys, nervous system, liver and gastrointestinal tract -- potentially leading to serious illness or death.

As part of the approval, the FDA sanctioned a new oral liquid form of the drug to allow for easier use in children, Roche said.

The drug has not been evaluated in transplant patients under 4 months of age, the company said.

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FRIDAY, Aug. 28 (HealthDay News) -- The U.S. Food and Drug Administration has approved Zenpep (pancrelipase) delayed-release capsules to treat a pancreatic disorder that prevents people from properly digesting food, Dutch drug maker Eurand NV said.

Exocrine pancreatic insufficiency (EPI) is caused by a lack of digestive enzymes produced by the pancreas, a possible symptom of conditions including cystic fibrosis and pancreatic cancer.

Zenpep was approved in different strengths for adults and children as young as a year old, Eurand said in a news release. It's expected to be available at U.S. pharmacies later this year.

The most common adverse reactions reported during clinical testing of Zenpep included gastrointestinal problems, abdominal pain, headache, cough and loss of weight, the company said.

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TUESDAY, Aug. 25 (HealthDay News) -- The antihistamine Xyzal (levocetirizine dihydrochloride) has been approved for children aged six months and older for indoor allergies and hives, drug makers UCB and Sanofi-Aventis said.

The medication, available as a liquid or pill, had been approved previously for people aged six years and older. The expanded approval also sanctions the drug's use to treat outdoor allergies in children aged two years and older.

Side effects of the medication may include fatigue, sore throat and dry mouth. Younger children may have additional adverse effects including fever, diarrhea, vomiting, ear infections and constipation, the drug makers said in a news release.

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FRIDAY, Aug. 21 (HealthDay News) -- Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children aged 1 month to 2 years, the agency said Friday in a news release.

Infantile spasms is characterized by severe seizures that typically start between ages 4 months and 8 months. Affected children tend to suddenly bend their bodies forward while their arms and legs stiffen. This behavior often occurs upon awakening or after the child eats, and may come in groups of up 100 spasms, the FDA said.

Underlying conditions that may give rise to the disorder include birth injury, metabolic problems and genetic abnormalities.

Sabril's label will include the agency's most severe "black box" warning that the drug's use could lead to progressive loss of peripheral vision, which could be dependent on dosage and duration of use, the FDA said. The drug will only be available via a restricted distribution program, and users will be required to undergo periodic vision testing.

Sabril was approved as an orphan drug, meaning the condition it treats affects fewer than 200,000 people in the United States, the agency said.

The drug is produced by Deerfield, Ill.-based Lundbeck Inc.

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THURSDAY, Aug. 20 (HealthDay News) -- Accelerated approval for Hiberix, a Haemophilus b Conjugate Vaccine, has been granted by the U.S. Food and Drug Administration, drug maker GlaxoSmithKline said.

Hiberix was approved as a booster dose for use in children ages 15 months to 4 years old to protect them from invasive disease caused by Haemophilus influenzae type b (Hib), RTTNews reported.

Hib disease is an often serious and potentially deadly bacterial infection that can cause meningitis.

The FDA's accelerated approval is meant to help deal with a shortage in the United States of a vaccine to protect infants from Hib. GlaxoSmithKline said the vaccine should be available within several weeks, RTTNews reported.

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TUESDAY, Aug. 18 (HealthDay News) -- A new drug can be used to treat patients with a rare genetic disorder called Gaucher disease before the drug gets full marketing approval, according to the U.S. Food and Drug Administration.

The Associated Press reported that the agency approved a treatment protocol that allows Protalix BioTherapeutics Inc. to give prGCD to patients in a clinical trial during a shortage of an older drug called Cerezyme, made by Genzyme Corp. That company had to discard most of its ingredients for Cerezyme after an FDA inspection of the manufacturing facility.

Under the treatment protocol, the patients in the clinical trial will receive prGCD for free until the drug receives full FDA approval, the AP reported.

Gaucher disease can cause liver and neurological problems.

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MONDAY, Aug. 17 (HealthDay News) -- Extavia (interferon beta-1b) has been approved by the U.S. Food and Drug Administration to treat multiple sclerosis, drug maker Novartis said Monday.

The drug was approved for people in whom the autoimmune disease has just relapsed, or for those in whom MS is newly diagnosed, the company said in a news release.

MS affects about 400,000 people in the United States, Novartis said, of whom about 80 percent have the relapsing-remitting form. In people with MS, the body's immune system attacks the protective tissue surrounding nerve fibers that transmit electric signals to the brain. Symptoms may include problems with muscle control, vision, balance, sensation and mental function.

Interferon beta 1-b has been used as a standard treatment for MS for more than 16 years, Novartis said.

Common adverse reactions among Extavia users include injection site reactions, flu-like symptoms, headache and pain. The medication should be used with caution in people with depression, the drug maker said.

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FRIDAY, Aug. 14 (HealthDay News) -- The drug Saphris (asenapine) has been approved by the U.S. Food and Drug Administration to treat adults with either schizophrenia or bipolar I disorder, the agency said Friday.

Symptoms of schizophrenia may include hearing imagined voices, seeing things that aren't present, and having thoughts that others are going to do you harm. This can lead to behavior including withdrawal, extreme fear, and violence.

People with bipolar I have alternating periods of depression and manic highs. Other symptoms may include restlessness, racing thoughts, and impulsive behavior.

Saphris is among a class of drugs called atypical antipsychotics, all of which must be labeled with the FDA's most serious "black box" warning, the agency said in a news release. The label warns of increased risk of death if the drugs are used by older people with dementia-related psychosis. These drugs aren't approved for this so-called "off-label" use.

Common adverse reactions recorded during clinical testing of Saphris included an inability to sit still (akathisia) and other movement disorders, drowsiness, decreased sensitivity in and around the mouth, and weight gain, the FDA said.

Saphris is produced by New Jersey-based Schering-Plough.

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TUESDAY, Aug. 4 (HealthDay News) -- The drug Avastin has been approved in the United States for treating people with metastatic renal cell carcinoma, the most common form of kidney cancer.

The U.S. Food and Drug Administration approved Avastin to be used in combination with the drug interferon-alpha, Agence France Presse reported.

A study found that people treated with a combination of the drugs lived nearly twice as long without disease progression compared to people treated with only interferon-alpha.

Since the end of 2007, Avastin has been available in Europe as a first-line treatment for advanced kidney cancer, AFP reported. Last week, European officials approved the drug for treatment of breast cancer.

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TUESDAY, Aug. 4 (HealthDay News) -- Livalo (pitavastatin) is the newest statin to be approved by the U.S. Food and Drug Administration to treat high cholesterol.

As with other statin drugs, Lavalo is meant for people in whom diet and exercise fail to lower cholesterol, the agency said in a news release. Statins do this mostly by curbing the liver's ability to produce an enzyme called HMG Co-A reductase.

Livalo was approved based on the results of five clinical studies that compared its safety and effectiveness to three other statins. The most common side effects reported among Livalo users were pain in the muscles, joints, and back, and constipation.

Livalo is produced by Montgomery, Ala.-based Kowa Pharmaceuticals America Inc.

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MONDAY, Aug. 3 (HealthDay News) -- Invega Sustenna (paliperidone palmitate) has been approved by the U.S. Food and Drug Administration to treat schizophrenia, drug maker Janssen said in a news release.

The longer-acting version of the previously approved drug should help prevent relapses commonly caused when schizophrenia patients fail to take a more frequent dose, the company said. Invega Sustenna is the first once-monthly injectable atypical antipsychotic approved in the United States for this use, said the release from Janssen, a division of New Jersey-based Ortho-McNeil-Janssen Pharmaceuticals.

Common side effects of the drug include injection site reactions, fatigue and dizziness, Janssen said. The drug should be used with caution by people who have any history of seizure disorder, diabetes or low white cell count.

Schizophrenia, for which there is no cure, is a severe brain disorder that affects about 1.1 percent of the U.S. adult population, the U.S. National Institutes of Health says. People with schizophrenia sometimes hear voices and may become convinced that others plan to hurt them.

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FRIDAY, July 31 (HealthDay News) -- Onglyza (saxagliptin) has been approved by the U.S. Food and Drug Administration to treat type 2 diabetes in adults, the agency said Friday.

The once-daily pill is meant to be combined with proper diet and exercise to help control blood sugar, the agency said in a news release. It's among a class of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, which are designed to have the pancreas produce more insulin after a person eats. Insulin helps the body maintain normal blood sugar levels.

Onglyza was approved based on results from eight clinical studies. Makers Bristol-Myers Squibb and AstraZeneca submitted their approval application before December 2008, when the FDA imposed new clinical-study standards designed to evaluate the cardiovascular effects of diabetes drugs. While there's no evidence of increased risk of cardiovascular problems among Onglyza users, the agency said it ordered a post-market study of the drug that will concentrate on cardiovascular safety among high-risk users.

The most common reported side effects from Onglyza include upper respiratory infection, urinary tract infection, headache and allergic reactions, the FDA said.

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FRIDAY, July 31 (HealthDay News) -- Colcrys has been approved by the U.S. Food and Drug Administration to treat acute gout and familial Mediterranean fever (FMF), two inflammatory disorders. The drug's active ingredient, colchicine, is derived from the dried seeds of the autumn crocus plant.

In a news release, the agency said colchicine has been used as a remedy to treat acute gout flares "for many years," despite that it hadn't been FDA approved. The agency said it was in the midst of a program to bring other similarly unapproved products under its regulatory authority.

A dosing study required for approval led the agency to recommend a lower dosing regimen for Colcrys that had been commonly prescribed, the news release said. This was designed to prevent gastrointestinal problems.

The FDA said it was alerting healthcare professionals of the lower dosing schedule and also warning that the drug had the potential for severe interactions with other medications.

FMF, common in Mediterranean nations but less so in the United States, has symptoms including fever, arthritis, and inflammation of the lining of the lungs and abdomen. Colcrys is now the first drug that's been FDA-approved to treat FMF, the agency said.

The drug is produced by Philadelphia-based Mutual Pharmaceutical Company Inc.

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FRIDAY, July 24 (HealthDay News) -- Eli Lilly's Forteo (teriparatide injection) has received expanded approval from the U.S. Food and Drug Administration to treat osteoporosis associated with long-term use of glucocorticoid medication, the company said Thursday.

Glucocorticoid therapy is commonly prescribed for inflammatory conditions including rheumatoid arthritis and obstructive lung disease. These drugs are among the most common causes of secondary osteoporosis, which increases users' risk of bone fracture, Lilly said in a news release.

As many as three of every 100 adults over age 50 use this type of medication, Lilly said, and of those, about half will eventually have an osteoporotic bone fracture.

In clinical testing among patients with glucocorticoid-induced osteoporosis, Forteo increased bone mineral density after 18 months of use by an average of 7.2 percent at the spine, 3.6 percent at the hip, and 3.7 percent at the neck, the company said.

The drug should never be used by children and young adults whose bones may still be growing. And in rare cases, users have developed a form of bone cancer called osteosarcoma. It's not known if the drug increased their risk, Lilly said.

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To learn more about glucocorticoid-induced osteoporosis, visit the American College of Rheumatology.

MONDAY, July 20 (HealthDay News) -- The vaccine for 2009-2010 seasonal influenza has been approved by the U.S. Food and Drug Administration, the agency said Monday.

Every year, experts from the FDA, World Health Organization (WHO) and U.S. Centers for Disease Control and Prevention (CDC) evaluate the prevalent strains of flu and decide which three are most likely to infect people during the upcoming season. Those strains are included in the seasonal vaccine.

This year's inoculation, the FDA stressed, won't protect against the H1N1 swine flu, which was declared pandemic by the WHO last month. Scientists and manufacturers are working on a separate vaccine for swine flu, the agency said in a news release.

This year's seasonal flu vaccine, to be produced by six manufacturers, will protect against these strains:

• an A/Brisbane/59/2007 (H1N1)-like virus
• an A/Brisbane/10/2007 (H3N2)-like virus
• a B/Brisbane/60/2008-like virus

Between 5 percent and 20 percent of the U.S. population contract the flu each year, the CDC says. More than 200,000 people are hospitalized, and about 36,000 die from it. The elderly, very young and people with chronic health problems are at greatest risk of flu's complications, the FDA said.

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THURSDAY, July 16 (HealthDay News) -- The potent opioid medication Onsolis (fentanyl buccal soluble film) has been approved by the U.S. Food and Drug Administration to treat breakthrough cancer pain, the agency said Thursday.

Onsolis delivers the medication fentanyl through an absorbable film that adheres to the inside of the user's cheek, according to an FDA news release. It's been sanctioned for people 18 and older who already use round-the-clock opioid medication to manage pain. Breakthrough pain occurs when severe flares of pain prove inadequate for daily pain medication.

Onsolis is subject to abuse, and was approved under the agency's Risk Evaluation and Mitigation Strategy program, which requires the drug's maker to submit a plan for managing its risks. Under a companion program, only registered prescribers and pharmacies will be able to dispense the drug, and only registered users will be able to receive Onsolis, the FDA said.

The drug was approved with the agency's most serious "black-box" label warning, stating that the medication is not meant to remedy pain from migraines, dental problems or procedures, or post-operative pain. The labeling also warns that the drug should be kept out of the reach of children.

Onsolis is manufactured by Aveva Drug Delivery Systems of Miramar, Fla.

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FRIDAY, July 10 (HealthDay News) -- The U.S. Food and Drug Administration has approved the Eli Lilly blood-thinner Effient (prasugrel) to prevent clots in people who have an artery-clearing procedure called angioplasty.

Angioplasty involves inserting a balloon-like device into a clogged artery to open the vessel. The procedure is usually followed by insertion of a stent, a wire mesh tube designed to keep the artery open. But blood platelets tend to gather around the stent, increasing the risk of a clot that could lead to a heart attack or stroke.

In a study involving 13,608 people, the percentage of those who had subsequent non-fatal heart attacks was reduced from 9.1 percent among people who took the blood-thinning drug Plavix (clopidogrel) to 7.0 percent among those who took Effient, the FDA said in a news release.

But the agency warned that people taking Effient were at greater risk for serious, and sometimes fatal, bleeding. Labeling for the drug will include a so-called "black-box" warning of this risk, noting that people with an urgent need for surgery or those with a history of a mini-stroke called a transient ischemic attack should not use Effient.

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MONDAY, July 6 (HealthDay News) -- The drug Alimta (pemetrexed) has been approved by the U.S. Food and Drug Administration to prevent progression of certain types of advanced or metastatic (spreading) lung cancer, the agency said Monday.

The drug, which hinders the needed absorption by certain tumors of B-vitamin folate, is newly approved for people whose tumor has shrunk or whose cancer has stabilized after chemotherapy.

Alimta was first approved in 2004 to treat the asbestos-linked cancer mesothelioma and, later, as an initial therapy for advanced non-small cell lung cancer, the FDA said in a news release.

Possible side effects may include blood cell damage, fatigue, nausea, loss of appetite, extremity numbness, and rash, the FDA said.

The drug is produced by Indianpolis-based Eli Lilly & Co.

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THURSDAY, July 2 (HealthDay News) -- Multaq (dronedarone) tablets have been approved by the U.S. Food and Drug Administration to promote a normal heart rhythm in people with atrial fibrillation or atrial flutter. These conditions cause the heart to beat too quickly and can prevent it from pumping blood correctly.

The drug's label, however, will contain a "black box" warning that the medication could cause deadly reactions in people with recent severe heart failure, the agency said Thursday in a news release.

In clinical testing involving more than 4,000 people, Multaq lowered the rates of cardiac hospitalization or death from any cause by 24 percent, compared to an inactive placebo, the FDA said. The most common side effects were diarrhea, nausea, vomiting, fatigue and weakness.

Multaq is produced by French drug maker Sanofi-Aventis.

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THURSDAY, June 18 (HealthDay News) -- An injectable eye implant approved by the U.S. Food and Drug Administration Thursday is the first product sanctioned to treat the eye disorder macular edema when it is caused by blockage of the retinal vein, the device's maker said.

The Ozurdex eye implant treats macular edema by delivering a high concentration of the corticosteroid dexamethasone.

Macular edema occurs when the eye's macula -- a part of the retina -- swells because of fluid accumulation from leaking or blocked retinal veins. In a news release, device maker Allergan, Inc. said retinal vein occlusion is a significant cause of vision loss and the second most common disease of the retinal veins, behind diabetic retinopathy.

The implant, which is biodegradable, was evaluated in a pair of clinical studies involving about 1,300 people.

The treatment, to be injected in a physician's office, is expected to be available later this year, Allergan said.

Common adverse reactions observed during clinical testing included increased pressure, eye pain, cataract and headache.

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To learn more about macular edema, visit the U.S. National Eye Institute.

FRIDAY, June 12 (HealthDay News) -- Caldolor, the first injected form of ibuprofen, has been approved by the U.S. Food and Drug Administration to treat pain and fever, the agency said in a news release.

The drug will be available only for hospital use in 400 milligram to 800 milligram doses, depending on whether the patient has acute pain or fever. It's particularly useful for patients who cannot take ibuprofen in its oral form, the agency said.

Clinical testing involving 319 women who had undergone an elective hysterectomy found they were much less likely to ask for morphine if given Caldolor. Nausea, flatulence, vomiting and headache were the most common adverse reactions.

The drug is produced by Tennessee-based Cumberland Pharmaceuticals Inc.

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WEDNESDAY, June 3 (HealthDay News) -- Palladia (toceranib phosphate) is the first drug to be approved by the U.S. Food and Drug Administration specifically to treat cancer in dogs, the agency said in a news release Wednesday.

The drug has been sanctioned to treat canine cutaneous mast cell tumors, which account for about one in five cases of skin tumors in dogs.

While these tumors may appear small, they can be life-threatening if not treated and removed, the FDA said. Palladia, among a class of drugs called tyrosine kinase inhibitors, kills tumor cells and cuts off the tumors' blood supply.

The drug's side effects may include diarrhea, loss of appetite, weight loss and bloody stools.

Palladia is produced by New York City-based Pfizer Animal Health Inc.

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