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Pfizer Inc. has agreed to pull Bextra off the market in response to an FDA request, making it the second COX-2 inhibitor to be pulled off the market because of cardiovascular risks.
Last September, Merck & Co.’s Vioxx was pulled off the market after a study showed it caused double the risk of heart attack and stroke. At a three-day meeting held in February, an FDA advisory panel had recommended Pfizer’s Bextra and Celebrex remain on the market, despite the majority of the panel agreeing they both posed heart risks. The panel also agreed Vioxx could return to the market.
Given the controversial safety status of all three COX-2 drugs, many people were not surprised that the FDA decided to go against the panel’s recommendations and remove Bextra from the market. Bextra has “no added advantage,” according to acting director of the FDA’s center for drug evaluation and research Steve Galson, as well as carrying “a special risk.” Bextra already carried the strictest FDA issued warning, a black box warning, because of the drug’s risk of a serious, life-threatening skin reaction called Stevens Johnson syndrome.
Bextra’s removal from the market opened the door for future litigation against Pfizer. Pfizer said it disagrees with the FDA’s position on Bextra, but the company has continued to defend the product up until the drug’s withdrawal. The company claimed that Bextra had no side effects, but now the FDA has removed it, which is expected to result in legal action.
A warning label will also be added to Pfizer’s Celebrex, and the FDA said older painkillers like aspirin and ibuprofen will have to carry warnings about the possibility of cardiovascular and gastrointestinal risks. Any possibility of a Vioxx return, in light of the Bextra removal, would be completely shocking, according to medical experts.
Bextra sales have also been suspended in the European Union, and Pfizer is holding talks with regulators in other parts of the world.