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-April 13, 2005
The U.S. Food and Drug Administration asked Pfizer Inc. to withdraw its arthritis painkiller Bextra from the market last week. The federal agency concluded the drug's risks outweighed its benefits, though Pfizer disagreed with the FDA's assessment.
Bextra belongs to a class of drugs called COX-2 inhibitors. Six months ago another COX-2 inhibitor, Merck & Co.'s Vioxx, was pulled from the market after a study linked the drug to increased risks of heart attacks and strokes.
An FDA advisory panel voted in favor of allowing Bextra to remain on the market in February by a slim margin. Though the FDA usually follows the panel's recommendations, the agency did not believe Bextra sales should continue.
In addition to increased risks of heart attacks and strokes all COX-2 inhibitors are linked to, Bextra is also associated to a potentially fatal skin disease called Stevens Johnson syndrome.
Since the U.S. Bextra recall announcement, Bextra has also been removed in other countries. Pfizer has decided to follow the FDA's rulings in the United Arab Emirates as well and remove Bextra. The company hopes Bextra will be re-introduced.For more information on bextra, please contact us.