September 30 is becoming a day of infamy for drug safety. Onthat date in 2004, Merck announced that rofecoxib (Vioxx) doubledthe risk of myocardial infarction and stroke, and the companywithdrew the drug from the market after 5 years of use in morethan 20 million patients. On September 30, 2006, a front-pagearticle in the New York Times reported that the Food and DrugAdministration (FDA) had issued a warning that the antifibrinolyticdrug aprotinin, widely used to reduce perioperative bleedingin patients undergoing cardiac surgery, could cause renal failure,congestive heart failure, stroke, and death.
Dr. Avorn is a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital both in Boston.
An interview with Dr. Avorn can be heard at www.nejm.org.
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