Bayer Withdraws Heart Surgery Drug from U.S. Market Following New Study Results Revealing Harm

Drug maker Bayer AG has recalled all remaining stocks of the anti-bleeding medication Trasylol (aprotinin) from the U.S. market after a New England Journal of Medicine Study demonstrated that the drug increased heart surgery patients' risk of death by 53 percent.

Canadian researchers compared rates of massive bleeding, organ failure, death and other serious complications in 2,331 heart surgery patients given either Trasylol, Cyklokapron (tranexamic acid) or Amicar (aminocaproic acid). The anti-bleeding drugs are often prescribed during high-risk heart surgeries.

The researchers found that while about 4 percent of surgery patients given either Amicar or Cyklokapron died, the death rate among Trasylol patients was 6 percent.

"This represents a 53 percent [higher] relative risk of dying," said researcher Paul C. Hebert, "which translates into for every 50 patients treated with aprotinin, one [extra] patient would die."

The experimental phase of the current study was halted in October 2007, when it became clear that Trasylol patients were dying at a much higher rate than those given other drugs. In November, Bayer temporarily suspended marketing of the drug in the United States, but left existing supplies on the market. Now even those stores have been recalled. The company still sells the drug in other countries, however.

Trasylol was introduced in 1987, based on studies demonstrating that it reduced bleeding in surgical patients.

"Future studies of drugs to prevent blood loss in cardiac surgery must be designed to look at death and other important clinical consequences, rather than only focusing on blood loss," said Wayne A. Ray, director of Vanderbilt University School of Medicine's Division of Pharmacoepidemiology.

Eric J. Topol, director of the Scripps Translational Science Institute and dean of the Scripps School of Medicine, questioned who was to blame for allowing Trasylol to place patients at risk for 20 years.

"Did the clinical community accept it too readily? Was the manufacturer not willing to do the appropriate trials?" he said. "The FDA [also] has to be considered part of the problem. Why weren't trials like this part of the early approval process, rather than getting the data many years later?"