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FDA advisory committees vote to keep Trasylol on the market
Two FDA advisory committees have voted to keep aprotinin injection (Trasylol, Bayer) on the market after examining the clinical trial data, observational studies, and public testimony regarding associated risks of renal dysfunction/failure, myocardial infarction, stroke, and death. The committees also recommended an updated product label to warn of the potential concerns of the drug and voted 17-0 in favor of conducting additional clinical studies to further assess the risk/benefit profile. Aprotinin is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in CABG patients at increased risk for blood loss/transfusion.