Health Canada

Health Canada

May 14, 2008 16:17 ET

Health Canada Comments on Trasylol and the Publication of the BART Study

OTTAWA, ONTARIO--(Marketwire - May 14, 2008) - In light of the May 14, 2008 publication in the New England Journal of Medicine of the BART study on the use of Trasylol (the brand name for aprotinin) during high-risk cardiac surgery, Health Canada would like to update Canadians on the status of Trasylol in Canada.

Trasylol is authorized for use during coronary artery bypass grafting (CABG) surgery to help reduce bleeding and the need for blood transfusions. The BART clinical trial included use of Trasylol during higher-risk cardiac surgeries for which Trasylol has not been authorized in Canada. The trial was stopped in October 2007 due to an increased number of patient deaths in the Trasylol group.

On November 5, 2007, Health Canada asked Bayer Inc., the manufacturer of Trasylol, to suspend the marketing of the product in Canada. No other product is authorized in Canada for a similar use. A limited access program was put in place by Bayer, in consultation with Health Canada, to make Trasylol available to physicians who conclude that the benefits outweigh the risks for patients undergoing CABG surgery. The use of Trasylol has significantly declined and no adverse events from this limited access program have been reported to Health Canada since the program was initiated. This program will remain in effect until Health Canada's ongoing safety review is completed.

Health Canada continues to review available safety information on Trasylol and will include the findings of the BART study as part of the review. The Department will convey new safety information to Canadians and health care professionals as necessary.

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