Update: Bayer Halts Sale of Antibleeding Drug Trasylol® Used in Coronary Artery Bypass Grafting Surgery

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Bayer AG suspended worldwide sales of Trasylol®, a clotting drug using during heart surgery to prevent bleeding, on Monday following a request from the U.S. Food and Drug Administration to remove the drug from the American market for safety reasons. "The FDA cannot identify a patient population in which the use of Trasylol® (aprotinin) outweighs the risk," Dr. John K. Jenkins, director of the FDA's Office of New Drugs, said at an early morning news conference Monday.

Trasylol® is designed to stem blood loss and to enable patients undergoing cardiac bypass surgery to avoid the use of blood transfusion. Trasylol® works by blocking enzymes that dissolve blood clots.

The suspension follows news last month that a major Canadian trial (named BART) of the drug was terminated because of an increase in deaths for cardiac surgery patients using it. The trial had been set to recruit about 3,000 adults who were candidates for a variety of cardiac surgeries and were at high risk of bleeding. BART was designed to show that Trasylol® was better than other drugs in controlling bleeding. Dr. Gerald Dal Pan, the FDA's director of the Office of Surveillance and Epidemiology, said, "That study was halted, because Trasylol® appeared to increase the risk for death compared with two other drugs."

Trasylol® was approved by the FDA in 1993. The agency began to re-evaluate the drug's safety after the January 2006 publication of two studies that linked the drug's use to serious side effects, including kidney problems, heart attacks and strokes. More recent studies have suggested the drug also raises the risk of death. One of those studies previously completed was withheld by Bayer from the FDA due to what the company investigation later characterized as a "regrettable human error."

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