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Pfizer Inc has suspended sales of Bextra (valdecoxib) in the United States and the European Union. The FDA cited cardiovascular risks and a risk of serious, sometimes fatal, skin reactions to the painkiller. Bextra falls into the class of drugs known as nonsteroidal antiinflammatory drugs (NSAIDs).
In a statement, Pfizer said that it "respectfully disagrees" with the FDA's position on the overall risk/benefit profile of the drug. The company said that it will work with the agency to look at options that may allow it to resume selling Bextra.
The FDA is also requiring Pfizer to add a black-box warning to its other COX-2 inhibitor NSAID, Celebrex (celecoxib). Celebrex and all other prescription NSAID COX-2 inhibitors must have a warning on their label that patients may face an increased risk of cardiovascular side effects or gastrointestinal bleeding, said the FDA. The warning stresses that any individual who recently had heart bypass surgery should not use prescription-strength NSAIDs. The FDA also announced that patients are to receive a special pamphlet with every NSAID prescription that explains the warnings in consumer-friendly language.
Prescription NSAIDs are not the only medications subject to warnings. The FDA will also make OTC NSAIDs (eg, ibuprofen, naproxen, and ketoprofen) include stronger reminders to take only low doses for a few days at a time to prevent the same risks of high-dose, long-term use.