Aprotinin Injection (marketed as Trasylol) Information - http://www.fda.gov/cder/drug/infopage/aprotinin/default.htmUpdated December 2006--New labeling for Trasylol has a more focused indication, a new Warning about renal dysfunction, a revised Warning about anaphylactic reactions, and a new Contraindication. Trasylol new labeling changes are:
- Indication and Usage-more limited and focused
Trasylol is now indicated for use only in patients who are at increased risk for blood loss and blood transfusion in association with cardiopulmonary bypass in the course of coronary artery bypass grafting. It should be administered only in the operative setting where cardiopulmonary bypass can be rapidly initiated.
A new Warning about renal dysfunction - Trasylol administration increases the risk for renal dysfunction and may increase the need for dialysis in the peri-operative period.
Stronger Warnings about anaphylactic reactions including a new Contraindication for previous aprotinin exposure. Anaphylactic reactions, including fatal reactions, are one of the important risks associated with Trasylol administration. As a consequence of the higher risk for anaphylactic reactions, administration of Trasylol to patients with a known or suspected exposure during the past 12 months is contraindicated.
