Learning from Aprotinin — Mandatory Trials of Comparative Efficacy and Safety Needed

Aprotinin, a hemostatic agent that inhibits the fibrinolytic enzyme plasmin,1 was approved by the Food and Drug Administration (FDA) in 1993 for reducing blood loss during coronary-artery bypass grafting (CABG). By 2006, aprotinin was prescribed for approximately 200,000 patients undergoing cardiac surgery worldwide.2 Aminocaproic acid and tranexamic acid are lysine analogues that inhibit the binding of fibrin to plasminogen and also reduce blood loss, but a specific indication for bypass grafting is not included on their labels.1 The safety of aprotinin was called into question in 2006 and 2007, when the results of an international cohort study by Mangano et . . .