Monitoring adverse drug events: The Food and Drug Administration MedWatch reporting system

Remarkable achievements in drug research have taken place over the past qua rter century. By the same token, clinical application of these developments continues to be an important cause of serious injury and death each year. In fact, adverse drug events (ADEs) are estimated to account for approximat ely 106,000 deaths in the United Slates each year (1), more than auto accid ents, suicides, and homicides combined. This consensus meeting of the American Society of Regional Anesthesia was h eld in response to more than 30 reports received by the Food and Drug Admin istration's (FDA's) MedWatch reporting system of spinal hematomas in patien ts undergoing epidural anesthesia who also received low-molecular-weight he parin. As a former medical officer in the Anesthetic and Critical Care sect ion of the FDA, I will briefly outline how MedWatch functions and suggest c hanges to make it more effective.