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Observational analysis reveals increased risks of renal failure and mortality with aprotinin in cardiac surgery, highlighting critical safety concerns.
The aprotinin story began in 1987, when investigators reported that the use of the drug in patients undergoing repeat open-heart surgery decreased the need for blood transfusion by a factor of 8.1 In 1993, the Food and Drug Administration (FDA) approved the use of aprotinin to reduce blood loss during coronary-artery bypass grafting, and the drug became widely used in cardiac surgery. In 2006, the use of aprotinin became controversial when the drug was associated with an increased risk of renal failure, myocardial infarction, stroke, and death in a large observational study.2,3 Two subsequent cohort studies also linked aprotinin . . .
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Ray et al. (2008) studied this question.
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