The Food and Drug Administration asked Pfizer to suspend sales of its anti-inflammatory drug Bextra, saying that the risks of the COX-2 inhibitor outweighed its benefits, and Pfizer agreed to do so until after further discussions with the FDA. The agency also asked Pfizer to include a boxed warning on its more widely sold COX-2 inhibitor, Celebrex, alerting consumers to potential increased risk of cardiovascular problems and gastrointestinal bleeding. The same request was made to all makers of prescription nonsteroidal anti-inflammatories, or NSAIDs. Manufacturers of over-the-counter NSAIDS were being asked to revise their labels to include more information about potential risks and a warning of possible skin reactions.
Pfizer said in a news release it "respectfully disagrees" with the FDA's overall risk-benefit determination of Bextra but will suspend sales pending further discussion. Pfizer said it also will suspend sales in the European Union at the request of regulators there. The FDA began reviewing the cardiovascular risks of NSAIDs after Merck & Co. voluntarily withdrew its COX-2 inhibitor, Vioxx, from the market in September 2004. -- by Cinda Becker