Bayer Pharmaceuticals Corporation Informs Health Care Professionals Of Important Safety Revisions To The Trasylol Label

Bayer Pharmaceuticals Corporation, in collaboration with the FDA, is informing health care professionals of important safety revisions to the U.S. product information for Trasylol(R) (aprotinin injection) following an FDA Advisory Committee meeting earlier this year. These safety revisions relate primarily to renal function and hypersensitivity.

Patient safety is Bayer’s primary concern and we believe updating the label and informing health care professionals about the appropriate use of Trasylol is very important.

In the U.S., Trasylol is now indicated 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.

Trasylol may cause anaphylactic reactions especially in patients with prior exposure to aprotinin within 12 months and is contraindicated in such patients. The high-dose regimen of Trasylol has been shown in clinical trials to increase the risk of serum creatinine level elevations greater than 0.5mg/dL above baseline. Careful consideration of the balance of benefits and risks is advised before administering aprotinin to patients with pre-existing renal impairment or those with other risk factors for renal dysfunction.

The current U.S. Prescribing Information for Trasylol is available on http://www.trasylol.com. If you wish to request further information, please contact Bayer Pharmaceuticals Corporation Clinical Communications at 1-800-288-8371.