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Pfizer's Bextra To Carry Heart Risk Warning, Says FDA

Agency says pain drug's benefits still outweigh risks

Jan 1, 2002 | The U.S. Food and Drug Administration said on Thursday that Pfizer's new pain drug Bextra will carry a labeled warning about a risk of cardiac and blood-clotting problems.

Bextra's updated labeling will say that patients who have recently had artery bypass graft surgery are especially at risk for heart and blood-clotting complications when taking the drug.

Bextra's new label will also warn of the pain therapy's link to two potentially fatal skin reactions: Steven -Johnson Syndrome and toxic epidermal necrolysis.

Pfizer shares closed at $27.37, down 47 cents.

Wall Street seemed sanguine about the label change. "One way to look at it is that it seems the FDA is comfortable with just re-labeling than yanking it from the market, at least at this point, said Scott Henry, an anlyst with Oppenheimer & Co.

"I don't think this a surprise to investors," he said.

Pfizer's drug in a class of painkillers known as Cox-2 selective non-steroidal anti-inflammatory drugs (NSAIDS)is approved to treat the symptoms of osteoarthritis and rheumatoid arthritis, and menstrual pain.

The therapy made headlines last month when FDA whistleblower David Graham in Capitol Hill testimony named Bextra as one of the drugs he considered unsafe for market.

FDA said it strengthened Bextra's labeling because the agency is still getting reports of serious skin reactions in patients taking Bextra, and that the condition seems to occur more often in patients on Pfizer's drug than in patients on other COX-2 therapies.

In addition, a new study of 1,500 patients showed that people who were treated with Bextra after having cardiac surgery had a higher incidence of heart attack, stroke, and clotting in the veins and lungs, the agency added.

However, the new labeling also notes that, based on what FDA knows now, Bextra's benefits still appear to outweigh its risks when used properly.

Last month, study results presented at an American Heart Association meeting in New Orleans showed that patients taking Bextra had double the risk of heart attack and stroke compared with those taking placebo.

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