Bextra Withdrawn From Market

Food and Drug Administration (FDA, Washington, DC, USA), which found that the overall risk-versus-benefit profile for the drug is unfavorable. The move follows mounting reports of serious cardiovascular and gastrointestinal effects caused by the drug.

The FDA is now asking all manufacturers of prescription NSAIDs, including Celebrex (celecoxib), to revise their labeling and provide a boxed warning highlighting the potential for increased risk of cardiovascular events and serious life-threatening gastronintestinal bleeding associated with their use. Manufacturers of nonprescription NSAIDs are also being asked to revise their labeling to provide more specific information about the risks of their individual products.

Both Bextra and Celebrex are the products of Pfizer, Inc. (New York, NY, USA). The company has agreed to suspend sales and marketing of Bextra in the United States, pending further discussions with the FDA. Pfizer has also agreed to work with the FDA on a boxed warning for Celebrex. The current re-examination of the cardiovascular risks of NSAIDs began after Merck (Whitehouse Station, NJ, USA) conducted a voluntary worldwide withdrawal of Vioxx (rofecoxib), another prescription NSAID. The FDA states that it will carefully review any proposal from Merck for resumption of marketing.

"FDA is providing the public information based on the latest available data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks,” stated Dr. Steven K. Galson, acting director of the FDA's Center for Drug Evaluation and Research.






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