Copyright The McClatchy Company Apr 8, 2005 The painkiller Bextra was taken off the market on Thursday, and the government wants similar prescription drugs to carry the strongest possible warnings about increased risk of heart attack and stroke among the millions who use them.
Pfizer Inc. suspended sales of Bextra in the United States and the European Union at the request of the Food and Drug Administration and European regulators. The company said that the FDA, in seeking Bextra's withdrawal, cited a risk of serious, sometimes fatal, skin reactions to Bextra on top of the risks shared by other similar drugs.
At issue are a broad class of painkillers known as nonsteroidal anti-inflammatory drugs, or NSAIDS. Bextra is a particular type of NSAID known as a Cox-2 inhibitor, a class of blockbuster sellers particularly popular among arthritis sufferers until a competitor -- Vioxx -- was pulled off the market last fall. That sparked questions about the safety of all similar drugs.
Pfizer's Celebrex still can sell, the FDA announced Thursday. But it, and all other prescription NSAIDS, must carry a black-box warning on its label that users might face an increased risk of cardiovascular side effects.
Scientists don't have enough information yet to tell if one of the remaining prescription painkillers is safer than another, FDA officials stressed. But, the agency decided that Bextra was more dangerous than its competitors because of the added skin side effect.
In addition to the prescription drugs, the FDA asked manufacturers of over-the-counter NSAID painkillers to revise their labels to clarify information about the risks of cardiovascular incidents, gastrointestinal bleeding and rare but serious skin reactions.
That doesn't mean the nonprescription drugs are dangerous, FDA officials stressed -- but the strengthened wording will make clear that patients should take those drugs at the labeled dosage for short periods of time.
For users of prescription-strength NSAIDS, the government said there was no reason to panic but that people should consult their physicians about which painkiller is best suited for them -- and to take the lowest effective dose. be05 0014 050411 N S 0000000000 00004033
Credit: The Associated Press