Discovery of Adverse Drug Reactions
- 22 April 1983
- journal article
- research article
- Published by American Medical Association (AMA)
- Vol. 249 (16) , 2226-2228
- https://doi.org/10.1001/jama.1983.03330400072029
Abstract
Following a Food and Drug Administration review of three major phase IV studies involving from 7,607 to 22,653 persons, it was determined that none of the studies resulted in the detection of new adverse drug reactions (ADRs). For two of the three drugs studied, new ADRs were identified after approval. The discovery of these new ADRs was attributed to physician case reports obtained through concurrently operating spontaneous reporting mechanisms. (JAMA1983;249:2226-2228)Keywords
This publication has 2 references indexed in Scilit:
- Data Entry Experience with the Flexeril™ Surveillance ProgramDrug Information Journal, 1979
- The Discovery of Drug-Induced IllnessNew England Journal of Medicine, 1977