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MILES' TRASYLOL FOR CORONARY BYPASS BLOOD-LOSS PREVENTION/REDUCTION "RESERVED FOR HIGH-RISK PATIENTS," FDA SUGGESTS; PROTEASE INHIBITOR APPROVED DEC. 29

Executive Summary

Miles' Trasylol (aprotinin), indicated for use in the reduction or prevention of blood loss in patients undergoing coronary artery bypass surgery, should be "reserved for high-risk patients," FDA suggested in a Dec. 30 press release. The agency explained that "severe allergic reactions can result from using [Trasylol] more than once in a patient." In addition, "kidney toxicity was also a problem in some patients in the [clinical] trials," FDA added.

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