FDA APPROVES NEW INDICATION FOR PLAVIX

The FDA has approved the use of Plavix (clopidogrel bisulfate) for patients who have had a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI), who are not going to have coronary artery repair.

A STEMI is a severe heart attack caused by the sudden, total blockage of an artery. In STEMI patients, Plavix prevents subsequent blockage in the already-damaged heart vessel, which could lead to more heart attacks, stroke and possibly death.

FDA approved Plavix in 1997 to decrease platelet function in people who suffer from acute coronary syndrome. Platelets are the sticky blood cells that help to form a clot and can contribute to blocked coronary arteries

Two studies support the effectiveness of Plavix in treating STEMI heart attack patients. One trial demonstrated that Plavix, when combined with other standard treatments including thrombolysis, a procedure to dissolve clots, reduced mortality and also reduced the combined number of recurrent heart attacks, strokes and deaths. It was a randomized, double-blind, placebo-controlled trial of 46,000 patients conducted in China.