FDA Indicates Trasylol May Increase Death Risk

The Food and Drug Administration (FDA) said in an early communication release that a heart bypass drug marketed as Trasylol, also known as aprotinin, may increase the risk of death. The FDA approved the drug in 1993. Only a month ago the FDA still suggested that Trasylol stay on the market, even though evidence had been mounting that linked the drug to a higher risk of patient mortality as well as other serious side effects.

Trasylol is a Bayer, Inc., product. The drug is used prophylacticly during heart bypass surgery to prevent major bleeding and to avoid the need for blood transfusions. It works by preventing enzymes from dissolving blood clots. There is accumulating evidence that compared to other drugs with similar capabilities, Trasylol appears to increase the risk of a patient's death through hemorrhage.

In January of 2006, two studies were published indicating that Trasylol has serious side effects, which include heart attacks, strokes, and kidney problems. This prompted the FDA to re-examine the drug's safety. Only a month ago the FDA maintained the drug should still be safe to use despite the likelihood that it increases the mortality risk. However, more recent studies provide more evidence for the increase in the death rate among patients when Trasylol was used. Bayer earlier withheld one of such studies from the FDA due to what the company now calls a "regrettable human error."

A Canadian study called "Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population"(BART), which was supposed to include 3,000 patients, was recently stopped when results indicated the increased risk of death due to the use of Trasylol. In the Canadian study, Trasylol was studied in regards to safety and effectiveness. Furthermore, the study also compared Trasylol to two other drugs used for the same purpose. Those drugs are epsilon-aminocaproic acid and tranexamic acid. It was determined that a continued enrollment of patients into the study would not change the finding of a higher mortality rate.

Bayer maintains the drug is safe. However, Bayer is also willing to work with the FDA and the drug regulatory bodies of other countries in order to re-assess Trasylol's benefits and the risk involved, when the drug is used as a treatment option. Label changes may be necessary.

According to the FDA, label changes as well as other actions might be necessary. However, further data collection and analyses must be performed to more thoroughly assess the findings before other regulatory steps are taken.