fdaMcNeil Announces New Dosing Instructions for Tylenol
Johnson & Johnson’s McNeil Consumer Healthcare Division is announcing new plans to lower the recommended dosing instructions for single-ingredient Extra-Strength Tylenol (acetaminophen) in an attempt to prevent accidental overdose and liver damage. The company also plans to reduce the maximum daily dose for Regular Strength Tylenol and other adult acetaminophen products in 2012. Labels on the bottles will now list the maximum daily dose as six pills, or a total of 3,000 milligrams, down from eight pills a day or …
FDA Drafts Rules on Dietary Supplements
The Food and Drug Administration is requesting public comment on a series of safety rules for dietary supplements, clarifying when and how manufacturers need to notify regulators about new ingredients. The new guidelines are meant to help clarify a 1994 law regulating new dietary ingredients in tablets, powders, liquids, and other supplements. According to the 1994 law, manufacturers need to file a safety notification with the FDA before marketing dietary ingredients not on the market when the law passed. But …
FDA Says Chantix Raises Heart Risk
Pfizer’s Chantix, a drug designed to help patients quite smoking, may lead to a small increase in cardiovascular problems such as heart attacks for patients who already have heart disease. The U.S. Food and Drug Administration is changing the label for Chantix after reviewing the results of a clinical trial. The trial showed that 700 smokers with cardiovascular disease who were treated with the drug found that Chantix was effective in helping them stop smoking for as long as one …
FDA: MS Drug Tysabri is Riskiest in Third Year of Treatment
Biogen Idec’s multiple sclerosis drug Tysabri poses the highest risk of brain infection during the third year of treatment, U.S. health officials warned on April 22. An infection called progressive multiform leukoencephalopathy (PML), occurs in an estimated 1.5 per 1,000 patients treated with Tysabri during months 25 to 36, the Food and Drug Administration said. The FDA reported that the PML risk was 0.3 per 1,000 patients during the first two years of treatment. After three years, the rate was …
FDA to Add Strictest Warnings to Bowel-Cleansing Drugs
Two prescription bowel-cleansing drugs commonly taken before colonoscopies will receive the sternest safety warnings available after nearly two dozen patients reported suffering severe kidney damage after taking the drugs, the Food and Drug Administration said. The drugs, Visicol and OsmoPrep, are oral tablets made by Salix Pharmaceuticals. The FDA has received more than 20 reports of kidney failure in patients taking the tablets, known as oral phosphate products. The drugs will now have new boxed warnings added to their packaging …
Glaucoma Drug Boosts Eyelashes, FDA Panel Says
A glaucoma drug appears to have another use: Making eyelashes longer, darker, and fuller. Allergan, the maker of the blockbuster cosmetic drug Botox, wants the Food and Drug Administration to approve its Lumigan glaucoma drug for use as an eyelash booster. The drug maker got preliminary approval this week from an FDA advisory panel, which voted to allow Allergan to move forward with company trials to determine whether the drug is safe for use on eye lashes. The FDA is …
Traces of Melamine Found in U.S. Infant Formula
The toxic industrial chemical melamine, which has been blamed for four deaths and 50,000 injuries in China since it was found in infant formula and other products in that country, has now turned up in a leading American brand of infant formula, the Food and Drug Administration said. Melamine is an industrial chemical used in the manufacture of can liners, flame retardant, cleaning products, fertilizers, and pesticides. Officials have said Chinese manufacturers may have intentionally added the chemical to infant …
Dermal Fillers Cause Serious Problems, FDA Says
Wrinkle-fighting dermal fillers like Juvederm, Restylane, Radiesse, and Perlane can have serious and unexpected health complications in users who are looking to shave years off their appearance, the U.S. Food and Drug Administration said. The agency said it has received 930 reports of health problems caused by the cosmetic products in the past six years. The problems included facial palsy (paralysis), disfigurement, severe allergic reactions, swelling, and other complications. Unlike Botox, which is a form of purified botulism and paralyzes …
Double-Dose Fears Prompt Heart Drug Recall
Drug-maker Ethex Corp. has announced a recall of five of its generic heart medications due to concerns some of the pills may contain life-threatening double-doses of active ingredients. Overdoses of the drugs could cause deadly heart arrhythmia, low blood pressure, respiratory failure, and other serious complications. The drug recall is being initiated as a precautionary move and no patient deaths or injuries have been reported, the Food and Drug Administration said. The generic drugs involved in the recall are: • …
FDA Warns About Injuries from Surgical Mesh
A type of surgical mesh used in procedures for the treatment of severe incontinence, cases of prolapsed uterus, and other women’s health problems has been linked to serious, but rare, complications, according to the U.S. Food and Drug Administration. Since 2005, more than 1,000 reports of injuries have been received regarding several types of surgical mesh used to repair pelvic organ prolapsed and stress urinary incontinence. The mesh, inserted into the vagina, can cause infection, pain including during sexual intercourse, …
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