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Bextra Pulled from Market & Warnings Added to ALL NSAIDs

Marie B. Walker
April, 2005

Today (April 7, 2005), the FDA announced that it has asked Pfizer to pull Bextra (valdecoxib) from the market. According to the FDA's statement, Bextra is being pulled because "the overall risk versus benefit profile for the drug is unfavorable."¹ Pfizer has agreed to comply with the FDA's request, but intends to have further discussion with the FDA on this issue.

The FDA has also asked Pfizer to provide a boxed warning on its drug Celebrex that highlights "the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with [its] use."¹ The FDA is asking all manufacturers of NSAIDs to provide this same warning on their own NSAID labels. Makers of over-the-counter NSAIDs are being asked to include information on their labels about the increased risk of cardiovascular events and gastrointestinal bleeding as well as a warning about potential skin reactions. The prescription NSAID labels already contain a warning about potential skin reactions.

A list of prescription and non-prescription drugs in this class (NSAIDs) can be found at http://www.fda.gov/cder/drug/infopage/cox2/default.htm

1. The FDA's news release on changes to NSAIDs is available at http://www.fda.gov/bbs/topics/news/2005/NEW01171.html.

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