OTTAWA, CANADA -- November 26, 2007 -- Bayer Inc. 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.
· Following consultation with Health Canada, the U.S. Food and Drug Administration (FDA), the German Federal Institute for Drugs and Medical Devices (BfArM), and other health authorities, Bayer has temporarily suspended marketing of Trasylol (aprotinin).
· This action follows the recent termination of the BART clinical study the preliminary interim data analysis from which indicated an increase in all-cause mortality (that almost reached conventional statistical significance for 30-day mortality) in patients receiving Trasylol compared to the other study drugs.
· During the temporary suspension of marketing, Bayer Inc. in consultation with Health Canada have 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.
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.
SOURCE: Health Canada
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