Bayer Temporarily Suspends Global Trasylol(R)...( LEVERKUSEN Germany and WEST HAVEN...),Health

LEVERKUSEN, Germany and WEST HAVEN, Conn., Nov. 5 /PRNewswire/ -- Following consultation with the German Federal Institute for Drugs and Medical Devices (BfArM), the U.S. Food and Drug Administration (FDA), Health Canada, and other health authorities, Bayer announced today that it has elected to temporarily suspend worldwide marketing of Trasylol(R) (aprotinin injection) until final results from the Canadian BART trial can be compiled, received and evaluated. The company took this global action following direction from the German BfArM and requests from the FDA and other regulators that Bayer temporarily suspend Trasylol marketing in their respective countries until final BART data were available. The BART study is an independent randomized, controlled trial being conducted in high-risk cardiac surgery patients.

Once the complete BART dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol. At that time the temporary marketing suspension will be reevaluated. Additionally, the U.S. FDA, Health Canada and other health authorities have 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. Bayer will work with the FDA, Health Canada, and any other authorities who wish to institute similar programs, to outline appropriate patient profiles and the specific details.

This action follows notification to Bayer and regulatory authorities that the BART Executive Committee had halted the trial 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 recei
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