THURSDAY, Aug. 17, 2006 (HealthDay News) -- The Sanofi Aventis heart drug Plavix (clopidogrel bisulfate) received new approval from the U.S. Food and Drug Administration on Thursday to treat a type of heart attack caused by the sudden blockage of an artery.
About 500,000 Americans annually have this type of severe heart attack, known as an acute ST-segment elevation myocardial infarction (STEMI), the agency said.
Plavix, first approved in 1997 to prevent dangerous blood clots, was granted new approval to prevent subsequent blockage in STEMI patients that could lead to more heart attacks or stroke, the FDA said. The new approval is aimed at patients whose doctors don't recommend an artery-clearing procedure known as angioplasty.
Plavix has been associated with serious side effects including bleeding, low white blood cell counts, and a condition called thrombocytopenic purpura, characterized by low platelet counts and spontaneous bleeding and clotting, the agency said.
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