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FDA Painkillers

By: Associated Press
By: Associated Press

The painkiller Bextra has been pulled from the market.

Pfizer says it has suspended sales of Bextra in the United States and the European Union at the request of the Food and Drug Administration and European regulators.

In seeking its withdrawal, Pfizer says the FDA cited a risk of serious skin reactions to Bextra. Pfizer says 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.

The FDA also wants other drugs in the same class, such as Celebrex and Vioxx, to carry the strongest possible warnings about increased risk of heart attack and stroke.

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 problems and gastrointestinal bleeding.


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