Aprotinin, marketed by Bayer under the brand name Trasylol, is an injectable drug used during heart surgeries to prevent excessive blood loss. This type of medication is referred to as an antifibrinolytic.
Disturbingly, however, according to two recent studies—one published in the New England Journal of Medicine in January 2006, and another in the medical journal Transfusion—patients injected with Trasylol were almost twice as likely to die, suffer renal failure or stroke, and were 50% more likely to have a heart attack than patients who were not given the drug.
It is estimated that as many as 10,000 patients now require dialysis treatments as a result of renal failure caused by use of Trasylol.
Less expensive medications also designed to reduce blood loss, the generic antifibrinolytic drugs aminocaprioc acid and tranexamic acid, were associated with no increased risk of renal, cardiac, or cerebral events. Studies found these drugs to be as effective as Trasylol, but without the increased risk or cost of Trasylol.
Compared even to the control group that received no medication to control bleeding, those given Trasylol had an increased risk of death.
As a result of the recently published article in the New England Journal of Medicine, the FDA has issued a public health advisory and a warning to physicians about the dangerous side effects of Trasylol.
The FDA warning advises physicians and other health care providers of the following issues:
- 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.
(source: US Food and Drug Administration)
In addition to the notification, in the same release, the FDA states its intent to carefully monitor the use of Trasylol in the future and to continue to gather information about negative reactions to the drug.
What You Can Do
If you or a loved one had surgery in which Trasylol was administered, and suffered any of the side effects associated with the drug—including heart attack, stroke, kidney damage, or other coronary and cerebral events—you deserve to be compensated for the damages suffered.
While lawsuits against major drug manufacturers such as Bayer can be long and difficult, patients and their families who have suffered losses as a result of careless and negligent practices deserve competent representation.
If you or someone you love has suffered because you were administered Trasylol, contact an experienced pharmaceutical injury attorney today to review your case with you and help you determine how to proceed.