Drug Recalls, Alerts & Warnings                 Showing: Last 12 Months |All Drug Recalls, Alerts & Warnings

The FDA is warning consumers again not to use the ShoulderFlex Massager, imported by King International and sold by various companies, due to serious potential health risks. The ShoulderFlex Massager is a personal massage device sold in retail stores, catalogs and over the Internet. It is intended to provide users with a deep tissue massage to the neck, shoulders and back area while lying down. Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury or even death from strangulation. There have been reports of one death and one near death, due to strangulation, associated with the use of this device. The FDA recommends that customers and consignees safely dispose of the ShoulderFlex Massagers so that the device cannot be used. The massage fingers should be removed and disposed of separately from the device; the power supply should be disposed of separately, as well.

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McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (McNeil) is voluntarily recalling certain lots of MOTRIN® IB 24 count COATED CAPLETS, MOTRIN® IB 24 count COATED TABLETS and MOTRIN® IB 24+6 count COATED CAPLETS from retailers. The products were distributed in the United States, Puerto Rico, Bahamas, Fiji, Belize, St. Lucia and Jamaica. This is not a consumer level recall, which means that consumers do not need to dispose of or return the product. There is no safety concern if consumers continue taking the product in accordance with its label; however, it is possible there may be a delay in experiencing relief. This action is not being undertaken on the basis of adverse events. McNeil is recalling these products because testing of product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date. Out of an abundance of caution, we are recalling all the listed products since there is a chance they could experience a similar problem as they approach expiration. If you have any questions or concerns, please call our Consumer Call Center at 1-888-222-6036 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time).

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The FDA and the FTC today issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as ¿homeopathic¿ for weight loss. Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and found in the urine of pregnant women. HCG is FDA-approved as an injectable prescription drug for the treatment of some cases of female infertility and other medical conditions. The letters warn the companies that they are violating federal law by selling drugs that have not been approved, and by making unsupported claims for the substances. There are no FDA-approved HCG drug products for weight loss.

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The FDA is warning consumers not to eat alfalfa sprouts or spicy sprouts from plastic bags labeled Evergreen Produce or Evergreen Produce Inc.The sprouts are possibly linked to 20 reported cases, including one hospitalization, of Salmonella Enteritidis in Idaho, Montana, New Jersey, North Dakota and Washington State. The strain of S. Enteritidis is rarely seen at this frequency.

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The FDA is advising parents, caregivers and health care providers not to feed SimplyThick, a thickening product, to premature infants. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition. FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers' breast milk or infant formula products.

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The FDA is warning consumers about a potentially harmful product represented as "ExtenZe," a dietary supplement for male sexual enhancement. The counterfeit product looks similar to the actual product, but contains hidden ingredients that can cause serious harm to consumers. The counterfeit product has the following lot numbers on the packages:

• LOT 1110075
• LOT F050899

FDA laboratory analysis confirmed that the counterfeit product contains tadalafil, or a combination of tadalafil and sildenafil --active ingredients in FDA-approved prescription medicines for erectile dysfunction. These ingredients are not listed on the product label. These ingredients may interact with other medicines, like the nitrates found in some prescription medicines such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. The counterfeit product is illegal and unsafe.

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The FDA and the FTC today announced a joint effort to remove products from the market that make unproven claims to treat, cure, and prevent sexually transmitted diseases (STDs). Among the products targeted in today's action are Medavir, Herpaflor, Viruxo, C-Cure, and Never An Outbreak.The agencies issued multiple letters to companies warning that their products violate federal law. The companies that received the warning letters claim that their products treat a range of STDs, including herpes, chlamydia, genital warts, HIV, and AIDS. These products, sold online and in retail outlets, have not been evaluated by the FDA for safety and effectiveness. The joint action is the first step in keeping these unproven items from being sold to the public and preventing consumers from being misled. The Warning Letters inform the companies that they have 15 days to notify the FDA of the steps they have taken to correct the violations cited.

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FDA warns companies to stop making MRSA claims for over-the-counter products. The FDA issued four warning letters to companies that manufacture and market over-the-counter (OTC) drug products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylococcus aureus bacteria (MRSA). Labeling and marketing materials for the affected products also claim that they can prevent infection from other disease-causing agents. In addition, the labeling of some of the firms hand sanitizing drug products make claims related to preventing infection from E.coli and/or H1N1 flu virus. The FDA does not have sufficient evidence demonstrating that these products are safe and effective for these purposes.

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The FDA is warning consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D. Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma. Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects.

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DeFranco & Sons is voluntarily recalling in-shell hazelnuts, also called filberts, and mixed nuts containing in-shell hazelnuts that have been linked to seven cases of E. coli O157:H7 in Michigan, Minnesota and Wisconsin. These nuts were distributed nationwide and to Canada Nov. 2 to Dec. 22, 2010. The in-shell hazelnuts may have been sold in 2-pound and 4-pound packages of mixed nuts, 1-pound packages containing only in-shell hazelnuts or in open bins of nuts in grocery stores. The FDA became of aware of the problem in late February and is actively working with the Centers for Disease Control and Prevention (CDC) and public health and agricultural agencies in those states where illnesses have occurred to investigate the source of the contamination.

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New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the FDA said today. Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug.
Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines. Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy

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The FDA took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States. Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC).  Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs' labels do not disclose that they lack FDA approval.

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The FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.

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At the request of the FDA, the U.S. Department of Justice today filed a complaint for permanent injunction against a Jamaica, N.Y.-based beverage company to prevent it from processing and distributing juice and other products. Hank J. Hagen and Milton S. Reid and their company, Mystical One LLC (also known as Mystical One Juice LLC), are charged with violating the Federal Food, Drug, and Cosmetic Act by failing to have a Hazard Analysis and Critical Control Point (HACCP) plan for certain juice products, such as the company's carrot juice products, and by failing to comply with current Good Manufacturing Practice (cGMP). The FDA requires all juice processors to prepare and implement HACCP plans that identify and control food hazards associated with their juices, and it requires all food manufacturers to follow cGMP. The FDA is not aware of illnesses associated with Mystical One¿s juice products.

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The FDA is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule. The FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury. Acetaminophen, also called APAP, is a drug that relieves pain and fever and can be found in both prescription and over-the-counter (OTC) products. It is combined in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin). Because of continued reports of liver injury, FDA proposes that boxed warnings, the agency's strongest warning for prescription drugs, be added to all acetaminophen prescription products.

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PRock Marketing LLC, is voluntarily recalling all lots of Fruta Planta and Reduce Weight Fruta Planta because FDA testing determined that the product contains sibutramine. Sibutramine is a drug that was withdrawn from the market in December 2010 for safety reasons. The FDA has received multiple reports of adverse events associated with the use of Fruta Planta and Reduce Weight Fruta Planta, including several cardiac events and one death. PRock Marketing¿s recall notice recommends that consumers destroy the product or return it to the company.

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The FDA is warning consumers not to eat desserts from Rolf's Patisserie of Lincolnwood, Ill., because they have been linked to several outbreaks of S. aureus food poisoning. The desserts are available through retail, wholesale and internet sales, and may not be labeled as coming from Rolf's Patisserie. Resellers include grocery stores. Rolf's Patisseries also distributes the products through a catering service and to institutions such as nursing homes. Rolf's Patisserie is contacting retailers and restaurants to remove and discard these products from their shelves. The FDA is working with the CDC and the State of Illinois and Cook County departments of public health to investigate the situation. Rolf's Patisserie has ceased production and distribution.

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The FDA announced the agency is working with Abbott Diabetes Care to recall 359 different lots of glucose test strips marketed under the following brand names:

• Precision Xceed Pro
• Precision Xtra
• Medisense Optium
• Optium;
• OptiumEZ
• ReliOn Ultima

These strips are used with Abbott's Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems. As many as 359 million strips may be affected by the recall. The blood glucose monitoring systems are not affected by this recall. The recall pertains to certain lots of these test strips distributed in the United States and Puerto Rico. Other Abbott Diabetes Care products are not affected by the recall. The test strips being recalled may give falsely low blood glucose results. False results may lead patients to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading. Both scenarios pose risks to a patient's health. The recall is related to the test strips' inability to absorb enough blood for monitoring. Strips exposed to warm weather or prolonged storage may be more likely to provide a false result. The test strips were manufactured between January and September 2010 and are sold both in retail and online settings directly to consumers, but are also used in health care facilities.

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The FDA is warning that accidental ingestion of Tessalon (benzonatate) by children younger than 10 years can result in serious side effects or death. Tessalon, approved by the FDA to treat symptomatic relief of cough in patients older than 10, may attract younger children because of the drug's candy-like appearance - a round, liquid-filled gelatin capsule. The safety and effectiveness of benzonatate in children younger than 10 years has not been established. A review of the FDA's Adverse Event Reporting System database from 1982 through May 2010 identified seven cases of accidental ingestion associated with benzonatate in children younger than 10.

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The FDA is warning consumers not to use Man Up Now capsules, marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure. The FDA analyzed Man Up Now and determined that it contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, this chemical may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure. When blood pressure drops suddenly, the brain is deprived of an adequate blood supply that can lead to dizziness or lightheadedness. To date, the FDA is not aware of any adverse events associated with the use of the product. However, sexual enhancement products that claim to work as well as prescription products, but that contain prescription strength drugs, are likely to expose unknowing consumers to unpredictable risks and the potential for injury or death. The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to consult a health care professional and to safely discard the product.

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The FDA says Vigor-25, a product marketed as a natural dietary supplement to enhance male sexual performance, should not be purchased or used because it contains sildenafil, the active ingredient in the prescription drug Viagra.

Sildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and can dangerously lower blood pressure. The FDA is investigating the reported death of a 26-year old man, possibly associated with the use of Vigor-25. The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to stop using such products and consult a health care professional and to safely discard the product.

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The FDA warned four companies that the caffeine added to their malt alcoholic beverages is an unsafe food additive and said that further action, including seizure of their products, is possible under federal law. FDA's action follows a scientific review by the Agency. The FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers. The FDA also performed its own independent laboratory analysis of these products. Experts have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication. The FDA said peer-reviewed studies suggest that the consumption of beverages containing added caffeine and alcohol is associated with risky behaviors that may lead to hazardous and life-threatening situations.

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The FDA, the state of Maryland, and Baugher Enterprise warn that Baugher's Apple Cider in half gallon and gallon containers, offered for sale in Maryland and Pennsylvania, is preliminarily linked with an outbreak of E. coli O157:H7 infections. Consumers who have any of this cider should not drink it and should dispose of the cider in a manner that prevents people or animals, including wild animals, from consuming it.

The FDA, DHMH and Baugher Enterprise are working together on the investigation.In addition, Baugher Enterprise has voluntarily recalled the cider from its distributors.

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The FDA and the Centers for Disease Control and Prevention join Costco Wholesale Corporation (Costco), in warning consumers not to consume Bravo Farms Dutch Style Gouda cheese (Costco item 40654), as this cheese may be associated with an outbreak of E.coli O157:H7 infections. Consumers should return this product to the place of purchase or dispose of it in a closed plastic bag and place in a sealed trash can to prevent people or animals, including wild animals, from eating them. The FDA, CDC and Costco are working together on the investigation and will update the public with more information as soon as it is available.

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The FDA is warning consumers that Hyland's Teething Tablets may pose a risk to children. The FDA recommends that consumers not use this product and dispose of any in their possession. The manufacturer is issuing a recall of this product. Hyland's Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis, however, has found that Hyland's Teething Tablets contain inconsistent amounts of belladonna. The FDA advises consumers to consult their health care professional if their child experiences symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using Hyland's Teething Tablets.

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The FDA asked manufacturers to add new warnings to labeling of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs primarily used to treat men with prostate cancer. The warnings would alert patients and their health care professionals to the potential risk of heart disease and diabetes in men treated with these medications. In May, the FDA said that a preliminary and ongoing analysis found that patients receiving GnRH agonists were at a small increased risk for diabetes, heart attack, stroke, and sudden death. The new labels will include updates in the Warnings and Precautions section about these potential risks.

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The FDA warned eight companies that their over-the-counter (OTC) chelation products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products. There are no FDA-approved OTC chelation products. The companies that received the warning letters claim that their products treat a range of diseases by removing toxic metals from the body. Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson's disease, Alzheimer's disease, macular degeneration, and other serious conditions. Some companies that received the warning letters also claim their products will detect the presence of heavy metals to justify the need for chelation therapy. Despite the claims of the companies that received warning letters, the effectiveness in treating any of the diseases listed is unsubstantiated. In addition, there are serious safety issues associated with chelation products, which can alter the levels of certain substances in the blood. Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure, and death.

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The FDA advised consumers who have Slimming Beauty Bitter Orange Slimming Capsules not to use the product. FDA warns that Slimming Beauty Bitter Orange Slimming Capsules contain the active pharmaceutical ingredient sibutramine, a prescription-only drug which is a stimulant. Sibutramine is not listed on the product label and could harm consumers, especially those with cardiovascular conditions. FDA lab tests reveal that the product contains excessive amounts of sibutramine that may be dangerous to people who have a history of cardiovascular disease, because it can lead to elevated blood pressure, stroke, and heart attack. Consumers who are otherwise healthy and who take the amount of sibutramine found in Slimming Beauty capsules can experience anxiety, nausea, heart palpitations, a racing heart, insomnia, and elevated blood pressure. Sibutramine also may interact with other medications and can cause serious side effects.

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The U.S. Consumer Product Safety Commission (CPSC) and the FDA warned consumers to stop using infant sleep positioners. Over the past 13 years, CPSC and the FDA have received 12 reports of infants between the ages of 1 month and 4 four months who died when they suffocated in sleep positioners or became trapped and suffocated between a sleep positioner and the side of a crib or bassinet. The FDA has never cleared an infant sleep positioner to prevent or reduce the risk of SIDS(Sudden Infant Death Syndrome). In addition, CPSC and the FDA are unaware of any scientific studies demonstrating that infant positioners prevent SIDS or are proven to prevent suffocation or other life-threatening harm. The American Academy of Pediatrics does not support the use of any sleep positioner to prevent SIDS.

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The FDA has issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated. Warning letters were sent to Johnson & Johnson, CVS Corporation and Walgreen Company. These mouth rinse products contain the active ingredient sodium fluoride. The FDA has determined that sodium fluoride is effective in preventing cavities but has not found this ingredient to be effective in removing plaque or preventing gum disease.

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The FDA is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of a rare and potentially fatal condition known as nephrogenic systemic fibrosis (NSF), if the drug is administered to certain patients with kidney disease. Three of the GBCAs - Magnevist, Omniscan and Optimark - will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease. All GBCA labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration. GBCAs are intravenous drugs approved by the FDA for use with magnetic resonance imaging or magnetic resonance angiography to help detect abnormalities of body organs, blood vessels and other tissues.

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The FDA is warning consumers to discard cheeses from Estrella Family Creamery because they may be contaminated with Listeria monocytogenes. Environmental samples and one product sample collected by the FDA during an August 2010 inspection at the facility have tested positive for L. mono. The company had previously recalled cheeses due to L. mono contamination, but resumed marketing in May 2010. Consumers who have the cheeses should throw them away in a sealed container. Consumers with symptoms of Listeria should consult their doctor.

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The FDA is warning consumers not to take TimeOut Capsules because they contain an active drug ingredient that can dangerously lower blood pressure. The product is marketed as a dietary supplement for sexual enhancement. TimeOut is labeled as "100% natural" and consumers may mistakenly assume the product is harmless and poses no health risk. TimeOut is distributed on Internet sites and online marketplaces as 2,500 mg capsules. Consumers who have TimeOut Capsules should stop using them at once. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or death.

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The FDA is warning consumers about the risk of ultraviolet radiation overdose with the Tootsie Tanner portable foot tanning device. Use of this device can lead to an overdose of ultraviolet radiation because its labeling recommends an improper duration of exposure to radiation and the device has an inadequate timer. The labeled exposure schedule indicates that the device may be used for 30 minutes, and the timer control permits 30 minutes exposure. Based on FDA testing, the maximum exposure time for this device is 20 minutes. The device fails to provide prominent warnings about the need for protective eyewear. Use of this product according to the labeling could result in an overdose of ultraviolet radiation, which may cause immediate and delayed serious eye and skin injuries.

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Eggs in their shells may put consumers at risk for salmonella. Fast facts:

1. The current recall of eggs in their shells, or "shell eggs," is part of an ongoing and intensive investigation into the cause of recent cases of Salmonella Enteritidis.
2. This recall affects shell eggs produced by Wright County Egg of Galt, Iowa and Hillandale Farms of Iowa. The eggs are packaged under different brand names and distributed nationwide.
3. The shell eggs may contain Salmonella Enteritidis (SE) and may cause serious illness.
4. Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems.
5. Consumers should throw away the product or return the product to the store.

Shell eggs under the August 13, 2010 recall are packaged under the brand names: Lucerne, Albertson, Mountain Dairy, Ralph's, Boomsma's, Sunshine, Hillandale, Trafficanda, Farm Fresh, Shoreland, Lund, Dutch Farms and Kemps. Shell eggs are packed in 6-egg cartons, 12-egg cartons, 18-egg cartons and loose eggs with Julian dates ranging from 136 to 225 and plant numbers 1026, 1413 and 1946.

Recalled shell eggs affected by the expanded recall are packaged under the brand names: Albertsons, Farm Fresh, James Farms, Glenview, Mountain Dairy, Ralph's, Boomsma, Lund, Kemps and Pacific Coast. Eggs are packed in varying sizes of cartons (6-egg, 12-egg and18-egg cartons, and loose eggs for institutional use and repackaging) with Julian dates ranging from 136 to 229 and plant numbers 1720 and 1942.

Dates and codes can be found stamped on the end of the egg carton or printed on the case label. The plant number begins with the letter P and then the number. The Julian date follows the plant number, for example: P-1720 223.

Eggs involved in a second recall are only eggs with the following plant numbers:
P1860 - Julian (production) numbers ranging from 099 to 230
P1663 - Julian (production) numbers ranging from 137 to 230

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The FDA is warning consumers not to eat frozen mamey fruit pulp sold under the La Nuestra or Goya brands. An investigation by the Centers for Disease Control and Prevention (CDC) and state partners showed an epidemiologic link between an ongoing outbreak of Salmonella typhi infections and the products. The CDC reports that at least nine people are ill with typhoid fever, caused by S. typhi. Ill individuals have reported consuming mamey fruit pulp, including mamey fruit smoothies at juice stands. Goya Foods Inc. and Montalvan's (La Nuestra) have voluntarily recalled the products. Consumers who have the recalled La Nuestra brand or Goya brand frozen mamey pulp in their homes are urged to discard them right away. Consumers also are urged to find out what brand of mamey products are being used in drinks prepared at juice stands and stores. This outbreak of S. typhi is not related to the current outbreak of Salmonella enteritidis linked to eggs in their shells.

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The FDA has warned that the drug Lamictal (lamotrigine), approved to treat seizures and bipolar disorder, can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection. The agency is working with the drug's manufacturer, GlaxoSmithKline, to update the prescribing information and patient medication guide to include this risk. Aseptic meningitis has a number of causes including, but not limited to, viruses, toxic agents, some vaccines, autoimmune diseases and certain medications, including Lamictal. Symptoms can include headache, fever, chills, nausea, vomiting, stiff neck and sensitivity to light. Hospitalization may be required.

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The FDA is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as "Miracle Mineral Supplement" or "MMS." The product, when used as directed, produces an industrial bleach that can cause serious harm to health. The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting and life-threatening low blood pressure from dehydration. Consumers who have MMS should stop using it immediately and throw it away. MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary.

MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions.

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The FDA is warning that inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets. Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. The FDA currently is reviewing reports of adverse events in children and pets who were inadvertently exposed to this topical estrogen product.

Patients using Evamist should not allow children to make contact with the area of the arm where Evamist is sprayed and should wash the child's skin with soap and water as soon as possible if contact does occur. Pets also should not be allowed to lick or touch the arm where Evamist is sprayed.

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The FDA is warning that certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used. Advair Diskus is an inhaler used to treat patients with asthma and chronic obstructive pulmonary disease. The inhalers found recently were the first from the stolen lots to be found in commerce. But more stolen product may still be on the market and the FDA continues to aggressively investigate the matter.

The lot numbers, doses, and quantities of the stolen Advair Diskus inhalers are:

Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose, Exp: Sep 2010 (14,400 inhalers)

Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose, Exp: Sep 2010 (11,200 inhalers)

Patients who have products with these lot numbers should immediately stop using them, contact GlaxoSmithKline¿s Customer Response Center at 888-825-5249, and follow up with their physician or pharmacist to obtain a proper replacement.

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The FDA warned that Que She, marketed as an herbal weight loss supplement, contains active pharmaceutical ingredients not listed on the product label that could harm consumers, especially those with cardiovascular conditions.

People who have purchased Que She should stop taking the product right away and consult a doctor. Advertised as "Slimming Factor Capsule" and as "an all-natural blend of Chinese herbs," Que She has been widely distributed on Internet sites such as the Bouncing Bear Botanicals website, and at retail outlets, including Sacred Journey in Lawrence, Kansas.

An FDA analysis of Que She found that it contains:

• Fenfluramine,a stimulant drug withdrawn from the U.S. market in 1997.
• Propranolol, a prescription beta-blocker drug.
• Sibutramine, a controlled substance and prescription weight loss drug.
• Ephedrine, a stimulant drug that is legally marketed over-the-counter for temporary relief of asthma.

These active pharmaceutical ingredients also may interact with other medications and result in a serious adverse event.

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The FDA has warned that the unapproved use of the malaria drug Qualaquin (quinine sulfate) to treat nighttime leg cramps has resulted in serious side effects and prompted the manufacturer to develop a risk management plan aimed at educating health care professionals and patients about the potential risks. Qualaquin is not FDA-approved to treat or prevent nighttime leg cramps. A review of reports submitted to the FDA's Adverse Event Reporting System (AERS) between April 2005 and October 1, 2008, found 38 U.S. cases of serious side effects associated with the use of quinine, the active drug in Qualaquin.

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The FDA is warning consumers that Magic Power Coffee, an instant coffee product marketed as a dietary supplement for sexual enhancement, contains an active drug ingredient that can dangerously lower blood pressure. Consumers who have Magic Power Coffee should stop using it at once. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or even death. In the case of Magic Power Coffee, the FDA collected and analyzed the product and determined that the product contains hydroxythiohomosildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. This chemical, like sildenafil, may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. Consumers and health care professionals should be aware of this problem and the health hazard it presents.

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The FDA warned consumers about a potentially harmful product represented as "Generic Tamiflu" sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu's active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.

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The FDA is warning of the potential risk of overdosing infants with liquid vitamin D. Some liquid vitamin D supplement products on the market come with droppers that could allow parents and caregivers to accidentally give harmful amounts of the vitamin to an infant. These droppers can hold a greater amount of liquid vitamin D than an infant should receive.

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The FDA has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. The agency is also adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for Alli and is working with the manufacturer to ensure that consumers can understand this new warning.

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The FDA warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of a class of medications called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk.

Proton pump inhibitors, available by prescription and over-the-counter (OTC), work by reducing the amount of acid in the stomach. Prescription proton pump inhibitors include esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Aciphex). Prescription proton pump inhibitors are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

OTC versions, used for the treatment of frequent heartburn, include omeprazole (Prilosec OTC, Zegerid OTC) and lansoprazole (Prevacid 24HR).

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The FDA has issued an urgent nationwide recall of raw alfalfa sprouts linked to Salmonella outbreaks in 10 states.

This recall affects raw alfalfa sprouts packaged and labeled as: Caldwell Fresh Foods alfalfa sprouts - 4-ounce plastic cups and 1-pound plastic bags and in 2-pound and 5-pound plastic bags in cardboard boxes with sticker affixed with the printed words "Caldwell Fresh Foods;" Nature's Choice alfalfa sprouts - 4-ounce plastic cups; California Exotics brands alfalfa sprouts - 5-ounce plastic clamshell containers. No other alfalfa sprouts are implicated in the outbreak.

The recalled products have been linked to an outbreak of Salmonella Newport infections in consumers in Arizona, California, Colorado, Idaho, Illinois, Missouri, New Mexico, Nevada, Oregon and Wisconsin.

The sprouts were distributed to a variety of restaurants, delicatessens and retailers, including Trader Joe's and Wal-Mart stores.

Salmonella is a bacterium that can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems.

Consumers and restaurant and delicatessen operators should not purchase, eat or use raw sprouts from Caldwell Fresh Foods. The sprouts should be returned to the place of purchase for a refund and disposal.

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The FDA is warning consumers about potentially serious side effects from mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel, an over-the-counter (OTC) product that should only be used on the skin. The FDA has received reports of serious side effects in people who have mistakenly swallowed the product. Some OTC Benadryl products are intended to be swallowed. However, Benadryl Extra Strength Itch Stopping Gel is only safe and effective when used, as directed, on the skin. People who swallow the gel can ingest a dangerous amount of the active ingredient, diphenhydramine. Large doses of diphenhydramine can result in serious side effects, such as unconsciousness, hallucinations and confusion.

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Freshway Foods announced a voluntary recall of certain romaine lettuce products because of the possible connection between the products and an outbreak of foodborne disease. The FDA supports this action. The outbreak, which is still under investigation, involves cases in Michigan, Ohio and New York of illnesses due to infection with E. coli O145, a harmful bacterium.

Freshway Foods says the recalled shredded romaine lettuce was sold to wholesalers, food service outlets and some in-store salad bars and delis in Alabama, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, West Virginia and Wisconsin.

Shredded romaine lettuce from Freshway Foods with "use by" dates after May 12 are not involved in this voluntary recall.

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The FDA has ordered Baxter Healthcare Corp. to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use in the U.S. This action is based on a longstanding failure to correct many serious problems with the pumps. The FDA believes there may be as many as 200,000 of these pumps currently in use. Further, the FDA is ordering the company to provide refunds to customers or replace pumps at no cost to customers help defray the cost of replacement. Infusion pumps are devices that deliver fluids, including nutrients and medications, into a patient's body in a controlled manner. They are widely used in hospitals, other clinical settings and, increasingly, in the home because they allow a greater level of accuracy in fluid delivery.

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Working in consultation with the FDA, McNeil Consumer Healthcare is implementing a voluntary recall of infant and children's liquid products due to manufacturing deficiencies that may affect quality, purity or potency. The products include certain liquid infant's and children's Tylenol, Motrin, Zyrtec, and Benadryl products. Some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. The FDA recommends that consumers stop using these products.

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The FDA is advising consumers not to purchase nor consume Vita Breath, a dietary supplement manufactured by American Herbal Lab Inc. of Rosemead, Calif., and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead.

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About 280,000 external defibrillators used worldwide in health care facilities, public places or in the home may malfunction during attempts to rescue people in sudden cardiac arrest, the FDA warned today. Faulty components in defibrillators manufactured by Cardiac Science Corp. may cause the devices to fail to properly deliver a shock. Other problems with the affected models may include interruption of ECG analysis, failure to recognize electrode pads and interference or background noise that makes the device unable to accurately analyze heart rhythm.

The 14 models, which include automated and semi-automated devices, are: Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E; CardioVive models 92531, 92532 and 92533; Nihon Kohden models 9200G and 9231; and GE Responder models 2019198 and 2023440. The FDA recommends that users obtain alternative external defibrillators and arrange for the repair or replacement of the affected units.

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The FDA announced that seven metered-dose inhalers (MDI) used to treat asthma and chronic obstructive pulmonary disease (COPD) will be gradually removed from the U.S. marketplace. These inhalers contain ozone-depleting chlorofluorocarbons (CFCs), which are propellants that move medication out of the inhaler and into the lungs of patients. Alternative medications that do not contain CFCs are available. The affected products and their phaseout dates include:

Tilade Inhaler (nedocromil): June 14, 2010
Alupent Inhalation Aerosol (metaproterenol): June 14, 2010
Azmacort Inhalation Aerosol (triamcinolone): Dec. 31, 2010
Intal Inhaler (cromolyn): Dec. 31, 2010
Aerobid Inhaler System (flunisolide): June 30, 2011
Combivent Inhalation Aerosol (albuterol and ipratropium in combination): Dec. 31, 2013
Maxair Autohaler (pirbuterol): Dec. 31, 2013

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The FDA has updated its website www.fda.gov with information about triclosan, a common ingredient added to many consumer products to reduce or prevent bacterial contamination. It may be found in antibacterial soaps and body washes, toothpastes and some cosmetics - products regulated by the FDA. The agency is engaged in an ongoing scientific review to incorporate the most up-to-date data and information into the regulations that govern consumer products containing triclosan. The FDA does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.

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The FDA has issued warning letters to six U.S. based medical spas and a company in Brazil for making false or misleading statements on their Web sites about drugs they claim will eliminate fat in a procedure called "lipodissolve," or for otherwise misbranding lipodissolve products. These U.S. companies have made claims that the drugs they use for their lipodissolve procedures are safe and effective, but these products have not been evaluated or approved by the FDA for this use.

Lipodissolve is a procedure involving a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body. It also is known as mesotherapy, lipozap, lipotherapy or injection lipolysis. The most commonly injected drugs are phosphatidylcholine and deoxycholate, usually in various combinations with one another. In some cases, other ingredients, including drugs or components of other products such as vitamins, minerals and herbal extracts, are added to the mixture. The FDA is not aware of any credible scientific evidence that supports the effectiveness of any of these substances for fat elimination, and their safety when used alone or in combination is unknown

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At the request of the FDA, U.S. Marshals seized a range of consumer products, including creams, capsules, tablets, gum, throat spray, and shampoos from a Haywood, Wis., manufacturer. The U.S. Attorney¿s Office filed a complaint alleging that the products are misbranded and unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act.

The company makes disease claims for propolis, royal jelly, bee pollen, and honey, which are the bee-derived ingredients used to make the drug products. Because of these claims, the products are new drugs and therefore subject to FDA regulation. The products are not FDA approved as safe and effective in treating any of the stated diseases or conditions.

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The FDA, along with several state agencies, is alerting consumers to an outbreak of campylobacteriosis associated with drinking raw milk. At least 12 confirmed illnesses have been recently reported in Michigan. Symptoms of campylobacteriosis include diarrhea, abdominal pain and fever.

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The FDA has warned patients and health care providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg. Although muscle injury (called myopathy) is a known side effect with all statins, today's warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug. Rhabdomyolysis is the most serious form of myopathy. It can lead to severe kidney damage, kidney failure and sometimes death. Simvastatin is sold as a single-ingredient generic medication and as the brand-name Zocor. It also is sold in combination with ezetimibe as Vytorin, and in combination with niacin as Simcor.

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The FDA has added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form. Plavix reduces the risk of heart attack, unstable angina, stroke and cardiovascular death in patients with cardiovascular disease by making platelets less likely to form blood clots. Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme CYP2C19. People who have reduced functioning of this enzyme cannot effectively convert Plavix to its active form. As a result, Plavix may be less effective in altering platelet activity in those people. These "poor metabolizers" may not receive the full benefit of Plavix treatment and may remain at risk for heart attack, stroke, and cardiovascular death.

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The FDA has warned health care providers and consumers about counterfeit surgical mesh being distributed in the U.S. under the C. R. Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where weakness exists. The warning is of particular significance to health care professionals and their patients with surgical mesh implants, as well as hospitals and surgical centers, operating room medical professionals and staff, and purchasing and risk managers. Investigations by the FDA and Bard show that numerous products, sizes and lots of counterfeit flat sheet polypropylene surgical mesh are not manufactured by Bard. The FDA is recommending that health care professionals do not use any counterfeit Bard surgical mesh, carefully examine all manufacturers' polypropylene surgical mesh products and packaging for lot numbers and anything unusual that might indicate counterfeit mesh.

Contact Bard at 800-556-6275 if they think they have one of the counterfeit products.

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The FDA is warning consumers in Puerto Rico that two hand sanitizers - "Bee-Shield Hand Sanitizer" with Aloe Vera (10 fl. oz. or 1 gallon bottles) and "MD Quality Hand Sanitizer" with Aloe Vera (10 fl oz. bottles) - contain high levels of a bacteria, Burkholderia cepacia, that can cause serious infections in humans. The hand sanitizers are distributed only in Puerto Rico. Burkholderia can cause harm when hand sanitizers are used on skin with cuts or abrasions. Infections caused by the microbe that start in the skin may progress farther into the body and require medical or surgical attention. Although no adverse effects with these products have been reported to the FDA, the agency is advising that consumers not use them and throw them away. A recent FDA inspection of the Puerto Rico Beverage facility found serious problems in meeting the FDA¿s current Good Manufacturing Practice requirements. Consumers who have used these products and experienced adverse effects should contact a health care professional. Health care professionals and consumers may report serious adverse events or product quality problems to the FDA's MedWatch Adverse Event Reporting program.

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The FDA has announced preliminary data suggesting that Invirase (saquinavir) in combination with Norvir (ritonavir) may have potentially important adverse effects on the heart.
When used together, the drugs may cause prolongation of the QT and PR intervals on an EKG. Prolongation of the QT interval may lead to a condition known as torsades de pointes, an abnormal heart rhythm. Prolongation of the PR interval may also lead to an abnormal heart rhythm known as heart block. With torsades de pointes or with heart block, patients may have lightheadedness, fainting or abnormal heartbeats. In some cases, torsades de pointes may progress to a life-threatening irregular heart beat known as ventricular fibrillation. Review of the data is ongoing. Preliminary findings suggest that some patients using Invirase and Norvir may be at higher risk for heart abnormalities leading to irregular heart rhythms.
Patients using Invirase should talk to their health care professional about any questions or concerns they have about Invirase.

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The FDA has warned consumers about the potential for serious side effects from mistakenly using Maalox Total Relief instead of other Maalox products. The two products are intended for the relief of different symptoms and contain different active ingredients. Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids. Both are available without a prescription as over-the-counter liquid medications. The maker of Maalox brand products has agreed to change the name of Maalox Total Relief to one that does not include the word "Maalox" and will change the drug's packaging to avoid further confusion. Maalox Total Relief's active ingredient (bismuth subsalicylate) is chemically related to aspirin and may cause similar harmful side effects such as bleeding. As such, Maalox Total Relief is not appropriate for individuals with a history of gastrointestinal ulcer disease or a bleeding disorder. Maalox Total Relief also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), nonsteroidal anti-inflammatory drugs (NSAIDS) and other anti-inflammatory drugs.

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The FDA has announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint "Securetouch+" Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation. Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products and imaging solutions.

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The FDA is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). Preliminary laboratory tests conducted by GlaxoSmithKline (GSK) - the maker of the FDA-approved over-the-counter weight-loss product - showed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking. GSK has determined that the counterfeit product has been sold over the Internet, but there is no evidence at this time that it has been sold through other channels, such as retail stores. The counterfeit Alli product looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:

Outer cardboard packaging missing a "Lot" code;

Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g., 05/12);

Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;

Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with "SEALED for YOUR PROTECTION;"

Contains larger capsules with a white powder, instead of small white pellets.

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The FDA is recommending that the public not consume any varieties of HAPPYTOT Stage 4 and certain varieties of HAPPYBABY Stage 1 and Stage 2 baby foods in pouches distributed by Nurture Inc. The firm is recalling these products because some pouches are leaking or swollen. Swollen or leaking pouches may indicate problems with the product, including possible contamination by bacteria that can cause illness, or that the packaging has been compromised and is at risk of bacterial contamination.

The varieties of these products that should not be consumed are as follows:

HAPPYTOT Green bean, pear & peas, NET WT. 4.22 oz. (120 g), UPC 8 52697 00127 9;

HAPPYTOT Sweet potato, carrot, apple & cinnamon, NET WT. 4.22 oz. (120 g), UPC 8 52697 00128 6;

HAPPYTOT Spinach, mango & pear, NET WT. 4.22 oz. (120 g), UPC 8 52697 00129 3;

HAPPYTOT Butternut squash & apple, NET WT. 4.22 oz. (120 g), UPC 8 52697 00130 9;

HAPPYTOT Banana, peach, coconut & prunes, NET WT. 4.22 OZ. (120 g), UPC 8 52697 00131 6;

HAPPYTOT Banana, peach & mango, NET WT. 4.22 oz. (120 g), UPC 8 52697 00132 3

HAPPYBABY Mango, NET WT. 3.5 oz. (99 g), UPC 8 52697 00134 7

HAPPYBABY Spinach Mango Pear, NET WT. 3.5 oz. (99 g), UPC 8 52697 00139 2

HAPPYBABY Apricot Sweet Potato, NET WT. 3.5 oz. (99 g), UPC 8 52697 00136 1

These meals are packaged in plastic pouches with plastic caps and are sold at retail stores nationwide. To determine if a specific product is part of this recall, consumers should examine product packaging for expiration date codes between October 2010 and January 2011. These expiration date codes are printed as the first seven characters of a 15-character string.

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The FDA is warning that patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel). New data suggest that when patients take both Prilosec and Plavix, Plavix's ability to block platelet aggregation (anti-clotting effect) may be reduced by about half.
Plavix is used to prevent blood clots that could lead to heart attacks or strokes in at-risk patients. Omeprazole, the active ingredient of Prilosec and Prilosec OTC, is a proton pump inhibitor (PPI) used to reduce the production of stomach acid and prevent stomach irritation.
Plavix does not have anti-clotting effects until it is converted or metabolized into its active form with the help of the liver enzyme, CYP2C19. Prilosec blocks this enzyme, thereby reducing the effectiveness of Plavix.

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The FDA notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products. Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed "unsafe" and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS). The FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS.

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The FDA is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal. the FDA determined that the product contains sulfoaildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. The product is distributed on Internet sites and at retail stores. It is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules.

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The FDA acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta. From April 2005 through October 2008, the FDA received 78 reports of problems with kidney function in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. The most common side effects associated with Byetta include nausea, vomiting and diarrhea. These side effects may have contributed to the development of altered kidney function. Patients who experience any of these symptoms should immediately discuss them with their doctor.

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The FDA sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient. Both medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The single-dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective. The agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.

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The FDA is warning consumers to use extreme care when purchasing products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir). One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets taped between two pieces of paper. When analyzed by the FDA, the tablets were found to contain talc and acetaminophen. The FDA also purchased four other products purported to diagnose, prevent, treat or cure the H1N1 influenza virus from other Web sites. These products contained various levels of oseltamivir but were not approved for use in the United States. Several of the products purchased did not require a prescription. All did not arrive quickly enough to treat someone infected with the H1N1 influenza virus or with an immediate exposure to it.

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The FDA warned four companies that they must stop marketing unapproved codeine sulfate tablets. These drugs, commonly called narcotics, are widely used to treat pain. These particular products have not received FDA approval and the agency has no evidence that they are safe and effective. Another manufacturer, Roxane Laboratories, markets FDA-approved codeine sulfate tablets and is able to meet the demand for the drug. The FDA does not anticipate a supply problem for codeine sulfate tablets.

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The U.S. Department of Justice, on behalf of the FDA, has filed a complaint for permanent injunction against Rel's Foods Inc. (Rel's) seeking to stop the company from manufacturing, producing and selling adulterated food products. Rel's prepares, processes and distributes a variety of ready-to-eat sandwiches to convenience stores, deli markets, liquor stores, mini-marts and gas stations in Nevada and California. The government's complaint alleges that Rel's has an extensive history of operating under unsanitary conditions.

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The FDA ordered manufacturers of certain types of pedicle screw systems, called dynamic stabilization systems, to conduct postmarket surveillance studies to collect clinical data on potential safety issues, including fusion rates and frequency of additional surgeries. Dynamic stabilization systems are used in spinal surgery; some are intended to provide stabilizing support to the spinal column during bone fusion. There are not enough clinical data to determine whether these dynamic stabilization systems provide enough spinal stability to allow for complete spinal fusion. The system components may loosen, bend or break over time. If fusion does not occur, a patient's condition could worsen and require additional surgery.

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The FDA alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common anti-clotting drug. To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug's unit dose. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

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The FDA announced a ban on cigarettes with flavors characterizing fruit, candy or clove. The ban, authorized by the new Family Smoking Prevention and Tobacco Control Act, is part of a national effort by the FDA to reduce smoking in America. The ban highlights the importance of reducing the number of children who start to smoke, and who become addicted to dangerous tobacco products. Flavors make cigarettes and other tobacco products more appealing to youth. Studies have shown that 17-year-old smokers are three times as likely to use flavored cigarettes as smokers over the age of 25.

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The FDA cautioned users of personal emergency response buttons worn around the neck of a potential choking hazard associated with this product. There have been at least six reports between 1998 and 2009 of serious injury or death, from choking after the cord on the Philips Lifeline Personal Help Button became entangled on other objects worn around the neck. The device is used primarily by seniors living independently, who feel they are at risk for falls or other medical emergencies. The button is intentionally designed to not break away when tugged, which prevents the button from accidentally falling off. However, because it does not break away, there is a risk of choking, including the possibility of serious injury or death. Letters are being sent to 750,000 customers and labeling of this product has been changed to include a warning against the potential choking hazard.

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The FDA is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA's authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product. Promethazine should not be administered into an artery or under the skin because of the risk of severe tissue injury, including gangrene, the boxed warning says. There is also a risk that the drug can leach out from the vein during intravenous administration and cause serious damage to the surrounding tissue. As a result of these risks, the preferred route of administration is injecting the drug deep into the muscle.

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The FDA announced that Care-Tech Laboratories Inc. and its principal officers, John C. Brereton and Sherry L. Brereton, have signed a consent decree, agreeing to stop the illegal manufacture, marketing and distribution of over-the-counter (OTC) antimicrobial drugs used to treat and prevent infection. Inspectors found that Care-Tech violated many provisions of the FDA's current good manufacturing practice (cGMP) regulations. The products also do not conform to any applicable regulations for OTC drug products and have not undergone an FDA review, and therefore are considered unapproved drug products.

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The FDA is reminding the public that stolen vials of the long-acting insulin Levemir still may be on the market. Evidence suggests that the stolen insulin was not stored and handled properly, and may be dangerous. The FDA has received multiple reports of patients who suffered adverse events due to poor glucose control levels after using a vial from one of the stolen lots. When the FDA first alerted the public to the theft in June, it reported that three lots of Levemir totaling 129,000 vials had been stolen in North Carolina. So far only about two percent of the total amount stolen has been recovered.

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The FDA is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical and the over-the-counter medication Alli. Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 required hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the US. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness and stomach pain.

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The FDA issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen. The products contain ibuprofen in combination with a variety of other active ingredients. These products, marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products.

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The FDA is advising health care practitioners and patients against using certain glucose monitoring technologies that employ a specific test strip when patients are also receiving therapeutic products containing non-glucose sugars. The non-glucose sugars in some therapeutic products can falsely elevate glucose results, which may prompt excessive insulin administration. These therapeutic products are mostly used in patients with serious medical conditions. The glucose test strips in question contain glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ), the chemical that reacts with the non-glucose sugars (maltose, galactose and xylose) contained in some therapeutic products. This combination can produce a falsely high test result. Most GDH-PQQ devices are used in health care facilities.

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