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Trasylol®: A Blood-Clotting Drug

Trasylol® is an FDA-approved blood-clotting drug used to reduce bleeding and to lessen the need for blood transfusions for people undergoing cardiopulmonary bypass (CPB) for coronary artery bypass graft (CABG) surgery. Trasylol® is the brand name that the manufacturer Bayer Healthcare Pharmaceuticals uses; the generic name of this drug is aprotonin. Trasylol® use has been linked to increases in the risk of stroke, encephalopathy, heart failure, and kidney damage. If you’ve had surgery and then experienced one of these complications, you should contact your physician to find out whether Trasylol® was used during the procedure.

FDA Public Health Advisory Regarding Trasylol®

The FDA approved Trasylol® in 1993 for the heart surgery procedures described above. In February 2006, the FDA issued a Public Health Advisory regarding Trasylol®, stating that they’re performing a new safety evaluation of Trasylol®. Although the FDA approved Trasylol® only for use in specific cardiac surgeries, Trasylol® is now also used during some other types of surgeries, such as orthopedic surgery. The FDA advisory describes the possible adverse effects of Trasylol® use and reminds physicians of the approved and unapproved uses of Trasylol®, and of the patient characteristics that can increase the risks associated with Trasylol® use.

The highly respected New England Journal of Medicine published a study in early 2006 concluding that the data obtained regarding Trasylol® and end-organ damage indicate that further use of Trasylol® is not “prudent.”