Articles
FDA Update: Week Of July 12, 2010
July 13, 2010
By Lori Clapper, Web Editor
J&J Recalls More Medicines
Johnson & Johnson subsidiary McNeil Consumer Healthcare is recalling 21 more lots of OTC medicines, including Tylenol for children and adults, several forms of Benadryl allergy tablets, and Motrin painkiller. These drugs were being sold in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad and Tobago, and Jamaica.
This latest round of recalls is related to the January 15 recall of 53 million bottles of products. Consumers had complained about the presence of a musty or moldy odor that was linked to the presence of a chemical called 2,4,6-tribromoanisole (TBA). A review found that packaging materials used in the lots had been shipped and stored on the same type of wooden pallet that was tied to the presence of TBA.
See the complete list of recalled products in McNeil's announcement.
Read the Reuters report about the most recent round of McNeil recalls.
FDA Weighs Benefits Of Obesity Pills
According to a Reuters report released last week, three biotech companies are seeking FDA approval for prescription obesity drugs.
Vivus is hoping to get FDA's blessing on its obesity drug, Qnexa. Before making a final decision on Qnexa, the FDA will seek input from outside advisors. If approved, Qnexa will be the first new prescription weight-loss drug approved in the United States in a decade.
Reuters also reports that the FDA tentatively plans to review Arena Pharmaceuticals' lorcaserin in September and Orexigen Therapeutics'Contrave in December 7.
Weight-loss drugs are a sensitive subject for the FDA, since most never gain approval, are pulled from the market, or come with severe side-effect warnings.
Read Reuters' report on the FDA's upcoming review of these obesity drugs.
See the Arena's press release on the FDA review of lorcaserin.
Herbal Supplement Deemed Harmful
Last week, the FDA announced that Que She weight loss capsules could potentially be harmful to consumers' health. These capsules have been marketed as herbal weight loss supplements. However, an analysis found that they contained active pharmaceutical ingredients that were not listed on the product label. The ingredients include ephedrine, propranolol, and fenfluramine — a stimulant removed from the U.S. market in 1997 because studies found it caused heart valve damage. All of these drugs pose risks to those with cardiovascular conditions and may also adversely interact with other medications.
