Important Safety Information and availability of Trasylol (aprotinin) - Notice to Hospitals

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November 23, 2007

To: Hospital Chief of Medical Staff

Please distribute to relevant Departments of General Surgery, Thoracic Surgery, Pediatric Cardiothoracic Surgery, Cardiothoracic Surgery, Hepatology, Surgical Oncology, Orthopedic Surgery, Anesthesiology, Critical Care Anesthesiology, Hospital Pharmacy and/or other Departments as required and post this NOTICE in an appropriate location in your institution.

Subject: Availability of Trasylol® (aprotinin)

Bayer Inc. (Bayer) would like to update you on important information concerning the availability of Trasylol^® (aprotinin). Trasylol^® is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in those patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft (CABG) surgery who are at increased risk for blood loss and blood transfusion requirement.

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

Health Canada, the US FDA, and other health authorities had indicated their interest in working with Bayer to create a program for use during the temporary suspension under which physicians 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 Inc. in consultation with Health Canada has developed a process to make Trasylol^® available for high-risk patients where the practitioner is of the opinion that Trasylol^® is required and falls within the current approved indication.

The BART Trial is an independent, investigator-led, Canadian clinical trial titled, Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population - The BART Study. The study was designed to compare Trasylol^® to epsilon-aminocaproic acid and tranexamic acid in decreasing the occurrence of massive bleeding associated with high-risk cardiac surgery. This randomized, controlled trial being conducted in high-risk cardiac surgery patients was halted after a planned periodic data analysis indicated reduced bleeding but also an increase in all-cause mortality (that almost reached conventional statistical significance for 30-day mortality) for patients in the aprotinin treatment arm compared to patients who received either aminocaproic acid or tranexamic acid. Bayer, Health Canada, the FDA, the German BfArM, and other regulatory authorities released information to the public regarding the halt of the trial, and Bayer posted guidance to physicians and health care providers regarding the use of Trasylol^® (aprotinin) on October 25.

Since October 25, Bayer has continued to work with Health Canada to evaluate appropriate next steps. Bayer has been informed that data are now being collected from centres 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 thorough evaluation can be conducted by Bayer and Health Canada, the Company will communicate publicly regarding any further actions that may be undertaken in response to the analysis of that information.

Bayer has posted information on this decision and this Notice to Hospitals on the Canadian Bayer HealthCare website. In addition, this Notice to Hospitals can be found on the Health Canada website.

Additionally, public information has been issued by Health Canada, the FDA, the German BfArM, and other health authorities. Subsequently, also in agreement with the various health authorities, Bayer will issue letters to health care providers in each market outlining the specific details of the temporary market suspension in their respective countries. Additional safety information and information regarding the proper use of Trasylol^® can also be found in the Canadian Product Monograph (CPM), which is available on the Canadian Bayer HealthCare website.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Health Canada advises that reporting rates determined on the basis of spontaneously reported postmarketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious and/or unexpected adverse reactions in patients receiving Trasylol^® should be reported to Bayer or Health Canada at the following addresses:

If you wish to request further information, or to get information on how to obtain Trasylol^® for high-risk patients where the practitioner is of the opinion that Trasylol^® is required and falls within the current approved indication during this temporary suspension of marketing, please contact Bayer HealthCare, Medical Information at (800) 265-7382.

Sincerely,

original signed by

Shurjeel H. Choudhri, MD, FRCPC
Senior Vice-President &
Head, Medical & Scientific Affairs
Bayer Inc.