Trasylol (Renal Failure)
New evidence demonstrates that Trasylol (aprotinin) can significantly raise the risk of heart attack, stroke and kidney failure in heart surgery patients.
This drug, which the FDA approved in 1993, is administered annually to about 250,000 people worldwide who undergo heart bypass surgery. Its purpose is to prevent excessive blood loss.
Double the risk of kidney failure and stroke
An article in the January 2006 issue of the New England Journal of Medicine showed that Trasylol doubled the risk of kidney failure and stroke, and raised the chance of heart failure or heart attack by 50%. [Timeline of events]
Cheaper alternatives to Trasylol were proven to be just as effective in limiting blood loss and did not cause any of the dangerous side effects.
Alternatives for controlling bleeding during heart surgery—such as aminocaproic acid and tranexamic acid—have proven to be safe and effective substitutes for Trasylol, and do not present serious side effects.
Cheaper, equally effective alternatives
Many alternatives are much less expensive than Trasylol. Some researchers estimate that $1 billion in health care costs might have been saved if alternative medications had been used instead of Trasylol.
“The least that should be done is to inform the patient that the risk of going on dialysis is increased two- to three-fold, and there are alternatives,” said Dr. Dennis Mangano of the Ischemia Research and Education Foundation, the main author of a 2006 study of Trasylol.” [More expert testimony]
Bayer AG insists the drug is safe, but the FDA is working to gather all available information and to evaluate its safety. In recent years, Bayer has seen a steady growth in the sales of Trasylol.
In December 2005, Bayer predicted that its annual sales could possibly exceed $615 million, making it one of the company’s most lucrative drugs.
Learn the answer to frequently asked questions about Trasylol and renal failure.
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