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Bayer drug faces FDA warning

Date published: 10/02/2006

The US Food and Drug Administration (FDA) has issued a warning over Bayer's Trasylol (aprotinin injection). Trasylol is used in heart bypass surgery to prevent blood loss, but two scientific publications have found higher risks of serious side effects including kidney problems, heart attacks and strokes in patients who undergo artery bypass graft surgery.

Dr Steven Galson, director of FDA's Centre for Drug Evaluation and Research, said: "FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications. "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."

Bayer responded in a statement by supporting the actions of the FDA but saying that it "believes that Trasylol is a safe and effective treatment when used in accordance with the product labelling". The FDA is advising doctors to limit the use of the drug to when it is essential for treatment and monitor toxicity in patients' kidneys, heart and central nervous system.

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