The Food and Drug Administration is warning physicians that the blood-loss prevention drug Trasylol (aprotinin injection) has been linked to higher risks of kidney problems, heart attacks, and strokes in patients who undergo coronary artery bypass graft surgery.
Aprotinin is the only product approved for the prevention of perioperative blood loss and of the need for blood transfusion during coronary artery bypass graft surgery.
In particular, physicians should be aware of the following:
▸ When using aprotinin, physicians 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 the drug's manufacturer (Bayer AG) or to the FDA's Medwatch program.
▸ Physicians should consider limiting use of the drug to situations in which the clinical benefit of reduced blood loss is essential to management of the condition and outweighs the risks.
▸ The FDA is working with the manufacturer to examine the safety and benefits of the drug in light of recent data.
▸ Physicians should discuss all major risks for heart bypass surgery with their patients, including the risks for bleeding and available means of lessening the risk.
The FDA is currently evaluating data from scientific literature and reports submitted to the MedWatch program to determine if label changes or other actions are warranted. The agency also anticipates discussing the existing data about the risks and benefits of the drug during an advisory committee meeting to be held some time in 2006. The committee also will consider if additional safety measures need to be taken.
To report adverse events to the MedWatch program, call 800-332-1088 or go to the program Web site, www.fda.gov/medwatchwww.fda.gov/cder/drug/infopage/aprotinin/default.htm