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February 7, 2007

Aprotinin—Are There Lessons Learned?

Author Affiliations

Author Affiliations: Division of Cardiothoracic and Vascular Surgery, Division of Clinical Effectiveness, Department of Surgery and Brody School of Medicine at East Carolina University.

JAMA. 2007;297(5):527-529. doi:10.1001/jama.297.5.527

This past year has been a complicated one for aprotinin, an antifibrinolytic serine protease inhibitor used to lessen bleeding in patients undergoing cardiac surgery with cardiopulmonary bypass. Thirteen years after the initial approval of aprotinin by the US Food and Drug Administration,1 the report by Mangano and colleagues2 in this issue of JAMA will intensify the debate about the benefits and risks associated with use of this drug. Perhaps more important, this aprotinin story illuminates the larger issue of postmarket safety evaluation surrounding drugs and devices in the current medical environment.