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FDA panel rules Celebrex increases heart risks

February 18, 2005

A committee of doctors and scientists has unanimously voted that Pfizer Inc.'s biggest selling prescription arthritis drug Celebrex significantly raises the risk of heart attacks and stroke.

Chairman of the panel, Alastair Wood, said four or five studies have shown significant cardiovascular hazards among COX-2 inhibitors, the class of drug Celebrex belongs to. Last September, Merck & Co. pulled its popular COX-2 drug Vioxx after research linked its use to increased risk of heart attacks and stroke.

Wood said, "It's important to recognize this is a far larger safety signal than seen for other withdrawn drugs." The committee still has to vote on whether the benefits of Celebrex outweigh the risks.

The FDA usually follows the recommendations of its advisory panels, and the news is likely to negatively affect Pfizer's sales of Celebrex even further. Pfizer has been anticipating the committee's recommendations in hopes of recovering to more than half the $3.3 billion sales recorded last year.

Part of a series of nine, multipart questions the FDA has asked the panel of outside doctors, scientists and statisticians to answer, the committee will also consider risks and marketing of Pfizer's other COX-2 drug Bextra and Merck's withdrawn drug Vioxx.

For more information on the Celebrex class action, please contact us to confer with a Celebrex Lawyer and learn your legal rights and options.

 

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