The US Food and Drug Administration today issued a public health advisory alerting doctors who perform heart bypass surgery, and their patients, that Bayer AG's Trasyolol (aprotinin injection), a drug used to prevent blood loss during surgery, 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.
"FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications. We are working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients," said Dr. Steven Galson, director of FDA's Centre for Drug Evaluation and Research.
FDA is working with Bayer to examine the safety and benefits of Trasylol in light of the recent data and the evolving practice of medicine, states the FDA release.
Trasylol (aprotinin injection) is the only product approved by FDA for the prevention of peri-operative blood loss and the need for blood transfusion among patients undergoing coronary artery bypass graft surgery. The drug aids the body's ability to stop bleeding and is used to lessen the bleeding risk during this surgical procedure.