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What is Trasylol® (aprotinin)?

Trasylol® (aprotinin) is a medicine derived from bovine lung tissue that inhibits certain enzymes that increase the risk for bleeding. Administering Trasylol® aids the body's ability to prevent bleeding and is commonly used in coronary artery bypass graft (CABG) surgery.

When was Trasylol® approved by the Food and Drug Administration (FDA)?

Trasylol® was approved by the FDA in 1993.

Why was Trasylol® approved for public use?

Early studies showed that patients receiving Trasylol® had less of a need for blood transfusions than patients receiving a placebo. These Trasylol® studies did not find an increase in the risk for serious side effects.

What health concerns have recently come to light regarding Trasylol®?

A January 2006 study in the New England Journal of Medicine suggested that Trasylol® may increase the risk of kidney damage, stroke, and heart attack in patients undergoing CABG surgery. More patients receiving Trasylol® experienced these events than patients receiving other medications or no medication at all.

A second study suggested that people receiving aprotinin may be at higher risk for kidney damage. This report used methods similar to those used in the New England Journal of Medicine but included a smaller number of subjects.

Was Trasylol® responsible for the serious side effects detected in the New England Journal of Medicine study?

The study suggests that Trasylol® was associated with the serious side effects. However, the limitations of the study require that the data be examined more closely by the FDA.

What should CABG patients do regarding this new information?

Coronary artery bypass graft surgery patients should be aware that the FDA is examining the safety of Trasylol®, in light of the recent studies. Patients should discuss all major risks of CABG with their doctors, including the risks for bleeding.

Are other drugs available to control bleeding during CABG?

No other medications are currently approved by the FDA for use to reduce blood loss and the need for blood transfusion in patients undergoing CABG surgery. However, other medications have been used by doctors in order to try to prevent bleeding during CABG.

If you or someone you know has undergone a coronary artery bypass grafting surgery and subsequently developed the onset of kidney failure, please use the form on the left to contact our law firm.