Dangerous Drugs - Trasylol
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 aids the body's ability to stop bleeding and is used to lessen the risk of blood loss and blood transfusion during this surgical procedure.
In 2006, the FDA issued a public health advisory, and Trasylol's labeling was revised to strengthen the drug's safety warning and limit its prescription to patients with only the greatest risk of blood loss during surgery. The FDA's actions came after two scientific publications linked Trasylol to higher risks of serious kidney problems, heart attacks and strokes in patients undergoing artery bypass graft surgery.
FDA advised 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.
- The 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.
In mid-October 2007, researchers at the Ottawa Health Institute stopped a study on Trasylol because the drug appeared to increase the risk for death compared to similar drugs in the study. Two weeks later, the FDA instructed Bayer to suspend marketing of Trasylol while U.S. health officials further examined risks found in the Canadian study. Because there are few drugs as effective as Trasylol to minimize bleeding during surgery, the FDA decided to maintain some flexibility, allowing doctors to phase out their use of the drug while the investigation was underway.
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