Health Canada Decision on Trasylol^® (aprotinin)

On September 21, 2011, Health Canada informed Canadians of the conclusion of its safety review of the heart-surgery drug Trasylol^® (aprotinin). Information on Health Canada's decision and on the changes to the prescribing information is available at the following links:

• Health Canada decision on Trasylol (aprotinin) - Information Update (2011-09-21): Information on Health Canada's decision.
• Summary Report - Expert Advisory Panel on Trasylol® (aprotinin): A summary report from the Expert Advisory Panel on Trasylol^®
• Final Report - Expert Advisory Panel on Trasylol® (aprotinin): The final report from the Expert Advisory Panel on Trasylol^® that was convened by Health Canada.
• Health Canada's Response to the Final Report of Expert Advisory Panel on Trasylol® (aprotinin): Health Canada's response to advice from the Panel.
• Expert Advisory Panel on Trasylol^® (aprotinin): Further information of the Panel and it's members.

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Information for health professionals and patients

• Trasylol (aprotinin) - Important New Safety Information - Notice to Hospitals (2011-09-19): A letter sent to health professionals by Bayer Inc., in collaboration with Health Canada, with important new prescribing information
• Trasylol (aprotinin) - Important New Safety Information - For the Public (2011-09-21): A letter to the public with important new prescribing information for patients
• Product Monograph: contains detailed prescribing and safety information for health professionals and patients (see Part III, "Consumer Information," for information for patients). For the Trasylol^® (aprotinin) Product Monograph, search by the Product Name "Trasylol^®" in Health Canada's Drug Product Database.

Related links

Previous communications on Trasylol^® temporary suspension and Health Canada's review:

• Information Update (May 14, 2008) - Health Canada Comments on Trasylol^® and the Publication of the BART Study
• Notice to Hospitals (November 23, 2007) - Important Safety Information and availability of Trasylol^® (aprotinin)
• Information Update (November 5, 2007) - Manufacturer temporarily suspends marketing of Trasylol^® in Canada