The number of serious adverse drug events reported to the U.S. Food and Drug Administration (FDA) more than doubled between 1998 and 2005, as did deaths associated with adverse drug events, according to a report in the September 10 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.A serious adverse drug event, as defined by the FDA, means an adverse event that resulted in death, a birth defect, disability, hospitalization, or was life-threatening or required intervention to prevent harm, according to background information in the article. Such events are voluntarily reported to the FDA through its Adverse Event Reporting System (AERS) and known as “MedWatch” reports. The reports come to the FDA directly or through drug manufacturers, who are then required to forward them.
