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Bayer Withdraws Antibleeding Drug Trasylol

Study finds drug carries increased risk of death

By Mark Huffman
ConsumerAffairs.com

November 5, 2007     Spanish

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Bayer has announced it is suspending sales of Trasylol worldwide amid evidence that the antibleeding drug may have a higher risk of death than similar drugs.

Last month, the FDA warned of the drug's dangers after it was notified that a Canadian research group stopped a study on Trasylol because the drug appeared to increase the risk for death compared to similar drugs used in the study.

In January 2006, the New England Journal of Medicine published an article which found that the drug might be linked to a doubled risk of kidney failure, as well as increased risk of heart attacks, heart failure and strokes.

The authors cautioned that "continued use is not prudent" and said two generic medications were safe alternatives.

In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.

Trasylol is an antifibrinolytic drug, used to slow the breakdown of blood clots and subsequent excessive bleeding. The data in the suspended trial also suggested that fewer patients receiving the drug experienced serious bleeding events.

In its announcement today, Bayer AG said it was suspending sales at the request of regulators in the U.S., Canada, Germany and other countries.

Trasylol is widely used in heart-bypass surgery. By reducing reduce blood loss, it helps patients avoid transfusions.

Trasylol was approved by the FDA in 1993 and raised safety concerns for at least the last year. It's the third drug to be withdrawn from sale in the U.S. this year as FDA responds to pressure to take a stronger role in policing drug safety.

The FDA said Bayer would withdraw the drug gradually so that alternate products can be produced and distributed to pharmacies.

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