The Food and Drug Administration recently issued a Public Health Advisory alerting doctors who perform heart bypass surgery, and their patients, that Trasyolol (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 (CABG).
One study, made on more than 4374 patients undergoing heart bypass surgery, shows that Trasylol raises the risk of a heart failure by 55 per cent and doubles the chance of a stroke
Another study concluded that Bayer's aprotinin, marketed under the brand name Trasylol, causes more than 11,000 patients worldwide to need kidney dialysis each year.
FDA thus advises health care providers to be aware of the following:
Physicians who use Trasylol (aprotinin injection) 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 (aprotinin injection) 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.
FDA is working with the manufacturer to examine the safety and benefits of Trasylol (aprotinin injection) in light of the recent data and the evolving practice of medicine.
Patients should discuss all major risks for heart bypass surgery with their healthcare providers. These include the risks for bleeding and the available ways to lessen the risk for bleeding.
