FDA OKs Warning Label For Pfizer's Bextra

The federal Food and Drug Administration approved new labeling Thursday for Pfizer Inc.'s Bextra drug to warn of possible serious skin reactions and heart-related problems for those who've experienced coronary bypass surgery. The federal regulatory agency said a new “black box” warning on the label will state that some patients have reported a serious and potentially fatal skin reaction, which the agency said is most likely to occur in the first two weeks of treatment. The agency said the label also would add a warning in bold type about possible heart attack, stroke and blood-clot problems in the legs and lungs of those undergoing coronary artery bypass graft surgery.

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