# Pfizer Suspends Sales Of Bextra



## M&M (Jan 20, 2002)

Posted to the Co-Cure list. Can you say AAAAAAAAARRRRRRRRRRRRGGGGGGGGGGGGGHHHHHHHHHHHHHHHH?**************************************Pfizer Suspends Sales of COX-2 Inhibitor Bextra at Request of FDA*Access this story and related links online:http://www.kaisernetwork.org/daily_reports...cfm?DR_ID=29198 Pfizer on Thursday suspended sales of the COX-2 inhibitorBextra in the United States and European Union after FDA andEuropean regulators requested the market withdrawal of themedication over potential safety risks, the AP/Yahoo! Newsreports. According to Pfizer, FDA cited the increased risk for"serious skin reactions" among patients who take Bextra, as wellas "the risks shared by other similar drugs," AP/Yahoo! Newsreports. FDA said that the potential safety risks of Bextraoutweigh benefits for patients. In a statement on Thursday,Pfizer said, "For now, patients should stop taking Bextra andcontact their physicians about appropriate treatment options."Pfizer officials said that the company "respectfully disagreeswith FDA's position regarding the overall risk-benefit profileof Bextra" and plans to discuss the issue with the agency.Related ActionsIn addition, FDA requested that manufacturers of other COX-2inhibitors and over-the-counter nonsteroidal anti-inflammatorydrugs revise product labels to include information about theincreased risk for cardiovascular events and gastrointestinalbleeding. FDA said that COX-2 inhibitor labels should includethe "strongest possible warnings about increased risk of heartattack and stroke," AP/Yahoo! News reports. FDA has studied thesafety of COX-2 inhibitors since Merck voluntarily withdrewVioxx from the market in September 2004. In February, an FDAadvisory committee recommended that Vioxx -- as well as Bextraand Celebrex, a second COX-2 inhibitor manufactured by Pfizer--remain on the market but include strong warnings aboutpotential safety risks. Steven Galson, acting director of theFDA Center for Drug Evaluation and Research, said, "Today'sactions protect and advance the health of millions of Americanswho rely on these drugs every day" (Cass, AP/Yahoo! News, 4/7).------------------------------


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