Pressured by regulators, the German pharmaceutical giant Bayer AG announced on Monday that it had agreed to withdraw the controversial heart surgery drug Trasylol after a Canadian study suggested that it increased death rates.
Dr. John K. Jenkins, a leading official of the Food and Drug Administration, said, “FDA could not identify a specific patient population where the benefits of using Trasylol could outweigh the risks.”
Because of concerns that supplies of alternative medicines could run short, the agency has asked for a phased withdrawal of the drug, which is given before heart surgery to reduce the risks of excessive bleeding.
Bayer said in a statement that it still believed Trasylol was beneficial when used as directed. The FDA said it would try to accommodate doctors who still wanted to use the drug by allowing Bayer to provide it as part of a study.
About 200,000 patients around the world received Trasylol last year, 110,000 of them in the United States, Bayer said. The drug, known generically as aprotinin, has had FDA approval since 1993.
Two weeks ago, researchers from the Ottawa Health Research Institute stopped a study of Trasylol in 3,000 heart bypass and valve surgery patients because although those given the drug bled less, they were half again as likely to die as those given two older alternatives. With the results so preliminary, the circumstances and timing of the deaths are among factors still unclear.
The researchers said the overall numbers were not large enough to be statistically significant, but that may have been because the study was not given enough time.
“The fact that this trial was stopped early weighed heavily in our decision” to request withdrawal of the drug, Jenkins said.
The FDA had asked the researchers and Canadian health authorities for complete results of the study before making a decision. But when the researchers said they would need at least six more weeks to comply, the agency decided to act.