Trasyolol is used to prevent blood loss during surgery. It has been linked by two scientific publications to higher risks of side effects, such as heart attacks and strokes.
"FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications," says Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research, in an FDA statement.
He adds, "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."
Trasylol (aprotinin injection) is the only product approved by FDA for the prevention of peri-operative blood loss and the need for blood transfusion among patients undergoing coronary artery bypass graft surgery. The drug helps the body to stop bleeding.
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.
FDA is working with the manufacturer to examine the safety and benefits of Trasylol 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.
