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.