New Trasylol warnings after BART study deaths

Germany's Bayer AG has issued guidance to physicians on its surgical clotting agent Trasylol (aprotinin injection), urging that it only be used in accordance with approved product labeling. The agent is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass as part of graft surgery who are at an increased risk for blood loss and blood transfusion.

The company issued the warning after the Data Safety Monitoring Board of the BART trial decided to stop the Canadian evaluation because there appeared to be an increase in all-cause mortality in patients in the Trasylol treatment arm compared to those who received either aminocaproic acid or tranexamic acid, the comparator antifibrinolytics used in the study.

The US Food and Drug Administration, which was informed of the BART results last week, also issued a statement saying that the most recent data support the results from other comparison studies of Trasylol discussed at a September 2007 joint meeting of the FDA's Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees. The FDA anticipates further review of the risk and benefits of Trasylol, which may result in additional labeling or other regulatory action. In the meantime, the agency recommends that health care providers review the risks and benefits of Trasylol outlined in the label and in the Early Communication about an Ongoing Safety Review, and discuss the information with their patients.