Bayer addresses Trasylol issue

Bayer Pharmaceuticals Corp., in collaboration with the U.S. FDA, agrees to inform all healthcare professionals of important safety revisions to the U.S. product information for Trasylol (aprotinin injection) following an FDA Advisory Committee meeting.

These safety revisions relate primarily to renal function and hypersensitivity.

In the U.S., Trasylol is now indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients who are at an increased risk for blood loss and blood transfusion for those undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery.

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 problems 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 Corp. Clinical Communications at 1-800-288-8371.

The effects of Trasylol use in CPB involve a reduction in systemic inflammatory response to surgery, which translates into a decreased need for allogeneic (blood donated from another individual), blood transfusions, reduced bleeding and decreased mediastinal re-exploration for bleeding.