FDA issues "advisory" on Bayer's Trasylol

The US Food and Drug Administration has issued a Public Health Advisory alerting doctors who perform heart bypass surgery, and their patients, that Bayer Healthcare's Trasylol (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.

The "FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications," said Steven Galson, Director of the 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," he added.

Company working with regulators