FDA committees recommend continued U.S. marketing of Trasylol.

FDA's Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of FDA have recommended that the agency continue to allow marketing of Bayer's Trasylol (aprotinin injection), used in coronary artery bypass graft (CABG) surgery.

However, the committees also recommended that Bayer amend the U.S. product label for Trasylol to provide additional prescribing guidance to physicians and also recommended that Bayer conduct additional clinical studies, including randomized controlled trials, to further assess the risk and benefit of Trasylol.

Trasylol is the only drug currently approved by FDA for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.

Bayer announced that the company will work with FDA on appropriate U.S. label revisions providing additional prescribing guidance to physicians, and as the committees recommended, will hold discussions with FDA to reach agreement regarding further clinical activities.