Bayer Stops Sale of Trasylol, a Heart Bypass Drug

The pharmaceutical company Bayer has stopped selling and marketing Trasylol, also known as aprotinin, after studies indicated it increases the risk of death through hemorrhage. This might be a new scandal for the company. In 2001 the company's drug Lipobay, a cholesterol-lowering drug, had been taken off the US market after it was linked to several deaths.

Before reaching this decision, Bayer had consulted with German Federal Institute for Drugs and Medical Devices (BfArM), the U.S. Food and Drug Administration (FDA), Health Canada, and other health authorities, which requested to temporarily suspend the marketing of Trasylol. The temporary suspension will be re-evaluated, once the results of the Canadian Bart study are complete. The Bart study is an independent study of the drug including high-risk cardiac surgery patients.

The Food and Drug Administration (FDA) said in an early communication release that a heart bypass drug marketed as Trasylol, also known as aprotinin, might increase the risk of death. The FDA approved the drug in 1993. 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 still maintains the drug is safe if used according to labeling instructions. However, Bayer will immediately inform doctors and hospitals in all countries, where the drug has been sold, of this new development.