The FDA today issued a Public Health Advisory alerting doctors and patients that Bayer’s Trasyolol (aprotinin injection), 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,” said Steven Galson, director of FDA's Center for Drug Evaluation and Research. “We're 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.”
The FDA said it is working with Bayer to examine the safety and benefits of Trasylol in light of the recent data and the evolving practice of medicine.
Trasylol 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. This surgery is done to bypass clogged arteries.
In January, research published in the New England Journal of Medicine concluded that patients using Trasylol, were at an increased risk of kidney failure, heart attacks and strokes, compared with patients taking alternative drugs, aminocaproic acid and tranexamic acid, or no drugs at all.
In the first nine months of last year, Trasylol was Bayer's fastest-growing drug, with global sales of just under $200 million.
Bayer says 150,000 patients received the drug in the US during 2005.