Bayer issues additional guidance to physicians on Trasylol

-Forbes

10/25/2007 - Bayer Thursday said it issued additional guidance to physicians on Trasylol after the BART Executive Committee halted a Canada-based trial being conducted in cardiac surgery patients.

The company said the BART (Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population) data safety monitoring board informed the executive committee that a periodic data analysis indicated an increase in all-cause mortality for patients in the aprotinin treatment arm.

The company said it immediately informed the U.S. Food and Drug Administration, Health Canada and other authorities.

Bayer recommends physicians use Trasylol should only be used 'to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.'

The stock was last at $84.25.

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