The US FDA has issued a public-health advisory alerting health care professionals who perform cardiac bypass surgery and their patients to two studies suggesting serious adverse events with aprotinin (Trasylol, Bayer).
One of the studies, published in the New England Journal of Medicine and reported on Omnus, found that aprotinin may be associated with increased risk of myocardial infarction, stroke and renal dysfunction. Another publication (Transfusion, on-line edition, January 20, 2006) also reported that aprotinin administration may increase the risk for renal toxicity.
The FDA points out that neither study was randomized, and both compared aprotinin to products that are not FDA approved for use in the management of cardiac surgery patients.
"FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications," said Dr. 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 advises health care providers to be aware of the following:
Physicians who use Trasylol should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart or central nervous system and promptly report adverse event information to Bayer, the drug manufacturer, or through the FDA Medwatch program.
Physicians should consider limiting Trasylol use to those situations in which the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs the potential risks.
Reference
Information for Healthcare Professionals: Aprotinin injection (marketed as Trasylol), FDA alert 2/2006
FDA Alert
Related editorial
Mangano, D. Tudor, I. et al. 2006, 'The risk associated with aprotinin in cardiac surgery', N Engl J Med, vol. 354, pp. 353-365
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