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Another Arthritis Drug Yanked From Market

FDA Asks Pfizer To Withdraw Bextra Because Of Risks

POSTED: Thursday, April 7, 2005
UPDATED: 10:28 am CDT April 7, 2005

The government has asked Pfizer to withdraw the painkiller Bextra from the market because it increases the risk of heart attack and stroke.

Pfizer has agreed to suspend sales and marketing of Bextra in the United States, pending further discussions with the Food and Drug Administration.

Regulators also want all other anti-inflammatory drugs in the same class to carry the strongest safety warning possible. Pfizer has also agreed to work with the FDA on the boxed warning for its other Cox-2 inhibitor, Celebrex.

The FDA also is asking manufacturers of over-the-counter nonsteroidal anti-inflammatory drugs to revise their labels to include information about the risks of cardiovascular incident and gastrointestinal bleeding.

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The FDA has been studying the safety of the Cox-2 inhibitors since Merck voluntarily pulled Vioxx from the market in after heart problems were reported in some users.

Advisers to the FDA in February recommended that people who depend on Celebrex, Bextra and Vioxx be allowed to continue to use them despite the health risks.

But the FDA said Bextra's risks outweigh its benefits. The agency cited a lack of adequate data on the safety of using Bextra in the long term, along with the increased risk of heart problems in short-term use.

The FDA also said there have been reports of serious skin reactions, and even deaths, in patients using Bextra. The agency said the risk of these reactions is unpredictable.

In a statement, Pfizer said it "respectfully disagrees" with the FDA regarding the overall safety of Bextra and plans further discussions with the government about the possibility of returning Bextra to the market. But for now, the company said patients should stop taking Bextra and contact their doctors about appropriate treatment options.

Pfizer will also suspend sales of Bextra in the European Union, at the request of European regulators.

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