Drug Safety

The National Association of Chain Drug Stores (NACDS) has released a statement "applauding" the rejection of California legislation that would have required a prescription for over-the-counter products containing pseudoephedrine, an ingredient in cold and allergy medications.

McNeil Consumer Healthcare is recalling one product lot of Tylenol 8-Hour caplets 50 count bottles to the retail level. McNeil is taking this action following a small number of complaints of a musty or moldy odor. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
 

The U.S. Food and Drug Administration warns patients and healthcare providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide will reflect this risk.

A panel of respected professionals from leading consumer packaged goods companies will face the industry press at Pack Expo International 2010 to offer their opinions on the latest developments in packaging.

FDA is reviewing data from a long-term study concerning possible cardiovascular risks with the drug Avandia, following a recent report from the U.S. Senate Finance Committee that showed a link between the type 2 diabetes drug and thousands of heart attacks. Avandia is manufactured by GlaxoSmithKline, which is also undergoing scrutiny related to the safety of its asthma drug Advair.

FDA and Roxane Laboratories Inc. worked together to ensure that the packaging and labeling of Roxane's newly approved Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) promote safe use and minimize medication errors, reports the Institute for Safe Medication Practices (ISMP) in its February 11 ISMP Medication Safety Alert! newsletter.

FDA has issued a warning letter to McNeil Healthcare stating that its Jan. 8 inspection of the company's Las Piedras, Puerto Rico, location identified significant cGMP violations. Since 2008, McNeil has received odor complaints regarding certain Tylenol products. In 2009, McNeil began recalling bottled OTC products after discovering that packaging may have been contaminated with a pallet pesticide. The recall now numbers 60 million bottles.

The Institute for Safe Medication Practices (ISMP) and the American Association of Eye and Ear Centers of Excellence (AAEECE) are urging the end of a voluntary package color coding system for eye and ear products. According to AAEECE, color coding of certain ophthalmic medications may relate to medication errors.