Information Update

2007-157
November 5, 2007
For immediate release

Manufacturer temporarily suspends marketing of Trasylol in Canada

OTTAWA - At the request of Health Canada, the manufacturer Bayer Inc. has temporarily suspended marketing of the drug Trasylol (aprotinin), pending a review of preliminary results from a clinical trial (the BART study) that suggested an increased risk of death. Bayer Inc. will work with Health Canada so that the drug can be made available to certain patients in cases where the doctor believes the potential benefit clearly outweighs the risk.

Trasylol is a drug used during heart bypass surgery to help reduce bleeding and the need for blood transfusions. Health Canada has been reviewing post market safety information for Trasylol and is actively evaluating the safety profile of this product. This evaluation will include examining the relevant findings from the clinical trial and an evaluation of the risks and benefits associated with the use of Trasylol.

Bayer Inc. has recently sent a notice to hospitals and physicians regarding the suspension of the BART study. Health Canada will continue to communicate information and recommendations related to this product to health professionals and the public.

Health Canada informed health care professionals about safety information for Trasylol on March 27, 2007 and on February 28, 2006.

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