Renal Failure Questions

Q: What is Trasylol, and what is it used to treat?
A: Trasylol, a drug derived from bovine lung tissue, inhibits certain enzymes that increase the risk for bleeding during and after heart surgery. It is made by Bayer AG.

Q: Why was Trasylol approved in 1993?
A: Clinical studies showed that patients who received Trasylol had less need for blood transfusions and less bleeding than patients who received a placebo. These clinical studies did not detect an increase in the risk for serious side effects.

Q: What is the concern regarding Trasylol?
A: A study published in the January 26, 2006, issue of the New England Journal of Medicine suggests that administration of Trasylol may increase the risk for serious side effects (kidney damage, heart attack and stroke) among some heart surgery patients.

Q: Have other studies indicated problems with Trasylol?
A: One other study suggested that Trasylol administration may increase the risk for clot formation within coronary artery bypass grafts. In this study, patients receiving Trasylol were compared with those receiving a placebo. The study reported that patients receiving Trasylol had an increased rate of bypass graft closure.

Q: Based on these reports, why doesn’t the FDA immediately remove Trasylol from the market?
A: The findings from the NEJM report differ from the data submitted to the FDA in 1993. These other reports indicate that Trasylol’s benefits outweigh its risks. But the FDA is re-examining all these findings in light of the NEJM report and other information.

Q: What should patients do about this new information?
A: They should be aware that the FDA is examining 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 surgery with their doctor, including the risks for bleeding and ways to decrease those risks. Those who have been injured may consider filing a Trasylol lawsuit.