FDA panel calls for warnings on popular painkillers

Celebrex, Vioxx, Bextra, and other COX-2 class painkillers would remain available but would be required to bear a strong warning in a highlighted black box on the label of the bottle or box, according to a recommendation of a Food and Drug Administration advisory panel.

Doctors would be required to give patients a written warning that the drugs increase the risk of heart attack or stroke. Drugs bearing a black box warning are subject to restrictions in advertising.

Manufacturer Merck Research Labs said it had pulled Vioxx off the shelves when the elevated risk of heart attack became known. Company spokesmen said it will reexamine its decision.The panel also was asked to assess the safety of nonsteroidal anti-inflammatory drugs like ibuprofen.

The panel recommended these drugs carry new warnings as well, though there was a consensus that some of the drugs are much safer than others.

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