The Aprotinin Story: Lessons in Drug Regulation and Safety

Issues of drug regulation and safety are a familiar concern within the pharmaceutical industry and often do not emerge until several years after a drug has been on the market. The antifibrinolytic drug aprotinin (Trasylol) was developed by Bayer Pharmaceuticals and approved to prevent excessive bleeding in patients undergoing coronary artery bypass grafting surgery. After several years of widespread use of the drug in cardiac procedures, two observational studies demonstrated a risk of aprotinin for serious complications such as renal failure and myocardial infarction. These observations led to a prolonged review of the drug’s safety label by the Food and Drug Administration and to the revelation that Bayer had withheld the results of a privately commissioned observational study which demonstrated these reported complications. This essay highlights the ethical issues raised by the aprotinin saga and discusses the importance of transparency, honesty, and clinical equipoise in drug regulation and safety.