Pfizer Suspends Sales of COX-2 Inhibitor Bextra at Request of FDA Over Potential Safety Risks
Pfizer on Thursday suspended sales of the COX-2 inhibitor Bextra in the United States and European Union after FDA and European regulators requested the market withdrawal of the medication over potential safety risks, the AP/Yahoo! News reports.
According to Pfizer, FDA cited the increased risk for "serious skin reactions" among patients who take Bextra, as well as "the risks shared by other similar drugs," AP/Yahoo! News reports. FDA said that the potential safety risks of Bextra outweigh benefits for patients.
In a statement on Thursday, Pfizer said, "For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options." Pfizer officials said that the company "respectfully disagrees with FDA's position regarding the overall risk-benefit profile of Bextra" and plans to discuss the issue with FDA.
In addition, FDA requested that manufacturers of other COX-2 inhibitors and over-the-counter nonsteroidal anti-inflammatory drugs revise product labels to include information about the increased risk for cardiovascular events and gastrointestinal bleeding. FDA said that COX-2 inhibitor labels should include the "strongest possible warnings about increased risk of heart attack and stroke," AP/Yahoo! News reports.
FDA has studied the safety of COX-2 inhibitors since Merck voluntarily withdrew Vioxx from the market in September 2004. In February, an FDA advisory committee recommended that Vioxx -- as well as Bextra and Celebrex, a second COX-2 inhibitor manufactured by Pfizer --remain on the market but include strong warnings about potential safety risks.
Steven Galson, acting director of the FDA Center for Drug Evaluation and Research, said, "Today's actions protect and advance the health of millions of Americans who rely on these drugs every day" (Cass, AP/Yahoo! News, 4/7).