Trasylol, also known by its scientific name aprotinin or bovine pancreatic tryspin inhibitor (BPTI), is an injection manufactured by Bayer Pharmaceuticals used to reduce bleeding during complex surgery such as coronary artery bypass graft surgery and cardiac bypass surgery.  Several scientific publications, including The New England Journal of Medicine, report that injecting Trasylol may increase the risk of serious side effects for patients undergoing coronary artery bypass grafting (“CABG”).  The side effects include the occurrence of serious kidney damage, heart attack (myocardial infarction) and stroke.  The publications also assert that more patients receiving Trasylol experienced these side effects than those patients receiving either medications not intended to decrease blood loss or other medications intended to decrease blood loss. 

Amid concerns about whether Trasylol posed such risks of side effects, on February 8, 2006, the FDA issued a health advisory alerting doctors and patients that Trasylol “has been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks and strokes in patients who undergo artery bypass graft surgery.”  On or around September 27, 2006, Bayer admitted to the FDA that they also conducted a study that revealed Trasylol’s association to the risk of stroke, congestive heart failure, kidney damage and death.  On December 15, 2006, the FDA issued a press release stating that it was revising the “labeling for Trasylol to strengthen safety warnings and limit usage” including a warning that Trasylol increases the possible risk for kidney damage.  On October 19, 2007, the FDA was notified of the Data Safety Monitoring Board’s (DSMB) recommendation to stop the distribution of Trasylol in the study entitled Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) - a study designed to test the theory that Trasylol was superior to aprotinin alternatives (e.g., epsilon-aminocaproic acid and tranexamic acid) in decreasing the occurrence of massive bleeding associated with cardiac surgery.  However, the BART study preliminarily concluded that aprotinin increases the risk of death.  On November 5, 2007, the FDA announced that Bayer agreed to a marketing suspension of Trasylol.  After two follow-up studies were published by The New England Journal of Medicine in February 2008 finding that aprotinin increased mortality rates, in May 2008, Trasylol was entirely and permanently withdrawn from the market.  

If you paid for Trasylol, with or without insurance reimbursement, and wish to discuss your possible legal remedies, or have other information regarding Trasylol that you would like to report, please submit a form, email us, or contact our Washington, D.C. office toll free at (877) 337-8000.