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Stent worries may help Plavix

Executive Summary

FDA's Circulatory System Devices Panel recommends extended use of Sanofi-Aventis/Bristol-Myers Squibb's Plavix (clopidogrel) for reducing risk of thrombosis associated with drug-eluting stents. During its Dec. 7-8 meeting, the panel suggested FDA align DES labeling with American Heart Association guidelines that the antiplatelet therapy be taken for up to a year if a patient does not exhibit excessive bleeding. An observational study published in the Dec. 5 Journal of the American Medical Association found better outcomes were achieved the longer patients took Plavix, up to one year. FDA is considering changing DES labeling to reflect the need for anticlotting regimens that last longer than the three months recommended for Johnson & Johnson/Cordis' Cypher sirolimus-eluting stent and the six months recommended for Boston Scientific's Taxus paclitaxel-eluting stent...

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