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Bayer, the maker of Trasylol®, would like to update you with important information concerning the availability of Trasylol® (aprotinin) in Canada. Trasylol® is indicated for use to reduce blood loss and the need for blood transfusion in those patients undergoing heart surgery such as coronary artery bypass graft (CABG) surgery. The most up-to-date information regarding Trasylol® is as follows:

• Following consultation with Health Canada, the Food and Drug Administration (FDA), the German Federal Institute for Drugs and Medical Devices, and other health authorities, Bayer has temporarily suspended marketing of Trasylol® (aprotinin).
• This action follows the recent termination of the BART clinical study that indicated an increase in death rate in patients receiving Trasylol® compared to the other study drugs.
• During the temporary suspension of marketing, Bayer in consultation with Health Canada have developed a process to make Trasylol® available for high-risk patients where the doctor is of the opinion that Trasylol® is required and falls within the current approved indication.

Once more information is available, Bayer with Health Canada will evaluate whether new data has any impact on the benefit-risk profile for Trasylol®. At that time the temporary marketing suspension will be re-evaluated.

Health Canada and the FDA had indicated their interest in working with Bayer to create a program for use during the temporary suspension under which health care professionals in these markets might request and receive Trasylol® for treatment of certain surgical patients with an established medical need. Therefore, during the temporary suspension of marketing, Bayer in consultation with Health Canada has developed a process to make Trasylol® available for high-risk patients in Canada.

Since October, Bayer has continued to work with Health Canada to evaluate the appropriate next steps regarding Trasylol® use. Bayer has been informed that data is now being collected from health centers throughout Canada and a final data analysis will be undertaken by BART trial investigators. Once more complete information is available from the BART study and a meticulous evaluation can be conducted by Bayer and Health Canada, the company will communicate publicly regarding any further actions that may be undertaken.

Reference:

"Health Canada Issues an Update on Availability of Trasylol (aprotinin)," docguide.com, November 2007.