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Bextra withdrawal leaves gap in arthritis treatment relief

-April 18, 2005

The FDA concluded the risks of Bextra outweigh the benefits and asked its manufacturer, Pfizer, to voluntarily withdraw the drug from the market. Though Pfizer disagreed with the FDA's request, the company announced April 7 that it would suspend sales pending further discussions with the agency.

Patients were advised to stop taking Bextra and to contact their physicians about alternatives, but the Bextra recall announcement came at a particularly controversial time. Just six months prior to the Bextra announcement, Merck & Co. announced it was recalling its similar arthritis painkiller Vioxx. The Vioxx recall sparked questions about the safety of all COX-2 inhibitor drugs, which also included Pfizer Inc.'s Bextra and Celebrex.

In conclusion to an FDA advisory panel meeting in February, the committee recommended the FDA allow Bextra and Celebrex to remain on the market, though most experts agreed the drugs presented potentially fatal heart attack and stroke risks. In addition to the cardiovascular risks, Bextra is also linked to a deadly skin disease called Stevens Johnson syndrome.

The FDA's recent Bextra ruling leaves just Celebrex as the only remaining COX-2 inhibitor available, but the agency asked Pfizer to revise the drug's label to include a black box warning and provide a medication guide for patients with every filled prescription. In addition, the FDA asked manufacturers of other prescription and nonprescription NSAIDs to carry the strong warning, highlighting the potential for increased cardiovascular risks and potentially life-threatening gastrointestinal bleeding.

Two drug recalls and quite a few increased safety warnings later, many of the 20 million Americans suffering from osteoarthritis are wondering where they are supposed to turn to manage arthritis and other chronic pain. All patients are encouraged to visit their individual physicians for treatment option plans.

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