fdaDoctors Call on FDA To Keep Cold Medicines Away From Children
Over-the-counter cough and cold medicines have unproven results and may be dangerous for young children, a group of doctors and consumer advocates said. The group is urging the U.S. Food and Drug Administration to ban the sale of popular products such as Dimetapp and NyQuil for use in children ages 2 to 6. The group of medical experts from various organizations also targeted the brands Triaminic, Tylenol, and PediaCare as being unsuitable for use in young children.
Chinese-Made Instant Coffee and Tea Recalled Over Contamination Fears
The U.S. Food and Drug Administration is warning consumers not to drink Mr. Brown instant coffee and milk tea products made in China because they may contain a potentially deadly chemical additive. Melamine, a toxic chemical used in the manufacturing of plastics that can be used to cheat food quality checks by imitating food protein, may be found in the beverages. The chemical has already been detected in Chinese-made candy, buns, and carton milk, officials said. The coffee and tea …
FDA Looking Into Link Between Anemia Drug and Deaths
The U.S. Food and Drug Administration is investigating whether a Johnson & Johnson anemia drug increases the chance of death in stroke patients. A German medical study found that 16 percent of stroke patients treated with the drug, Eprex, died within three months of taking the drug, compared to just nine percent who died after receiving a placebo. The study was designed to test whether Eprex might improve brain function in stroke patients, which is an unapproved use of the …
Boston Scientific Earns FDA Approval for Next Generation of Drug-Eluting Stents
Boston Scientific Corp. has won U.S. regulatory approval for its next generation drug-eluting stents, the company announced. The company plans to immediately launch its Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System, the only drug-eluting stent on the U.S. market for use in vessels as small as 2.25 mm in diameter. Stents are tiny wire-mesh tubes that are inserted into diseased arteries to prop them open after they have been surgically cleared of blockages. The use of stents has decreased in …
FDA Warns Covidien to Clean Up Manufacturing Safety Problems
Medical-device maker Covidien Ltd. must correct safety violations at its Missouri manufacturing plant or else face fines and other penalties, the FDA said. FDA inspectors have uncovered manufacturing problems at the plant, which makes the Ultra-TechneKow DTE Generator. The machine provides medical isotopes that are used for radiopharmaceuticals injected into patients before imaging tests are performed. In an August 12 letter to the company, the FDA warned that the company had failed to establish appropriate standards and testing procedures for …
FDA Cracks Down on Unapproved Eye Washes, Skin Creams
Companies that sell eye washes and skin creams that have not been evaluated or approved by the Food and Drug Administration must either file for FDA approvals or stop selling the products within 60 days, federal officials said. The eye wash, known as a balanced-salt solution, is designed to keep eyes moist during surgical procedures. While Alcon Laboratories and Akorn, Inc., currently manufacture and sell FDA-approved eye washes, three companies — B. Braun, Baxter, and Hospira – market unapproved eye …
FDA: Chinese Infant Formula Brands May Be Tainted
The U.S. Food and Drug Administration is warning consumers about Chinese infant formula that may contain a toxic chemical additive and be available at some ethnic grocery stores in the United States. Federal safety officials are advising consumers to avoid Chinese infant formula after several brands were found to contain melamine, a toxic chemical commonly used in making plastics that has been linked to developmental problems in children. No Chinese brands of infant formula are approved for sale in the …
Diabetes Medication Byetta Linked to Pancreatitis, FDA Orders Stronger Label Warning
Byetta, a Type 2 diabetes drug made by Amylin Pharmaceuticals, Inc., has been linked to six cases of hemorrhagic or necrotizing pancreatitis. Two patients have died and four others are recovering after being hospitalized, according to the U.S. Food and Drug Administration. The recent incidents have prompted the FDA to develop stronger, more prominent warnings for the product’s label to alert consumers about the risk of acute hemorrhagic or necrotizing pancreatitis. Physicians are being cautioned to consider anti-diabetic therapies other …
Alcohol-Dependency Drug Causing Complications
Nearly 200 people treated with an injectable drug for alcohol dependence have suffered complications such as abscesses that required surgery to drain, the Food and Drug Administration said. Vivitrol, made by Alkermes Inc. and marketed by Cephalon Inc., is an extended-release form of generic naltrexone that is used in patients being treated for alcohol dependence when the patients can abstain from drinking alcohol before receiving the drug therapy. The FDA has received 196 reports of Vivitrol patients developing swelling, pain, …
Combined Drugs Can Cause Muscle Injuries, Kidney Failure and Death, FDA Warns
Taking two separate drugs used to lower cholesterol and treat irregular heart beat can result in a rare muscle injury, kidney failure, and death, the Food and Drug Administration warns. The drugs, amiodarone and simvastatin, can have adverse reactions in users and lead to development of rhabdomyolysis. Symptoms of rhabdomyolysis may include unexplained muscle pain, cramps, tenderness, weakness, stiffness, or spasm. People who are age 65 or older, who have uncontrolled hypothyroidism, and renal impairment may be predisposed to developing …
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