Adverse-Drug-Reaction Monitoring

Abstract

The U.S. Food and Drug Administration (FDA) has long been conducting a program to monitor reported adverse drug reactions to approved drugs. The purpose of this paper is to review the rationale for monitoring adverse drug reactions, to describe the current program, and to encourage physician participation in the program. The program began in the late 1950s, after the registration by the American Medical Association of cases of aplastic anemia due to chloramphenicol.1 It expanded greatly when the 1962 revision of the Food and Drug Act required the pharmaceutical industry to report adverse drug reactions to the FDA. Since 1969, . . .