By GARDINER HARRIS
Published: November 6, 2007
WASHINGTON, Nov. 5 — Pressured by regulators, the German pharmaceutical giant Bayer AG announced 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, “F.D.A. 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 F.D.A. 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 F.D.A. approval since 1993.
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