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Article: FDA approves warning label for Pfizer's Bextra drug.
- Article from:
- Knight Ridder/Tribune Business News
- Article date:
- December 10, 2004
CopyrightCOPYRIGHT 2004 Knight-Ridder/Tribune Business News. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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By Anthony Cronin, The Day, New London, Conn. Knight Ridder/Tribune Business News
Dec. 10--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 ...