Adverse-Drug-Reaction Monitoring

TLDR

The FDA has monitored adverse drug reactions since the late 1950s, expanding its program after the 1962 Food and Drug Act revision that mandated industry reporting. The paper reviews the rationale for monitoring ADRs, describes the current program, and encourages physician participation. No additional information provided.

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, . . .