Bayer announces Trasylol label revisions

Bayer Pharmaceuticals, the US subsidiary of Germany's Bayer Healthcare, in collaboration with the Food and Drug Administration, is informing health care professionals of important safety revisions to the US product information for Trasylol (aprotinin injection) following an FDA Advisory Committee meeting earlier this year. These safety revisions relate primarily to renal function and hypersensitivity.

In the USA, 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.

Bayer notes that the drug may cause anaphylactic reactions especially in patients with prior exposure to aprotinin within 12 months and is contraindicated in such subjects. 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 company says.