Exploring the FDA adverse event reporting system to generate hypotheses for monitoring of disease characteristics

Clin Pharmacol Ther. 2014 May;95(5):496-8. doi: 10.1038/clpt.2014.17. Epub 2014 Jan 21.

Abstract

The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) is a database for postmarketing drug safety monitoring and influences changes in FDA safety guidance documents such as drug labels. The number of cases in the FAERS has rapidly increased with the improvement of submission methods and data standards and thus has become an important resource for regulatory science. Although the FAERS has been predominantly used for safety signal detection, this study explored its utility for disease characteristics.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adverse Drug Reaction Reporting Systems*
  • Data Mining
  • Databases, Factual
  • Drug Labeling
  • Drug-Related Side Effects and Adverse Reactions*
  • Humans
  • Product Surveillance, Postmarketing / methods*
  • United States
  • United States Food and Drug Administration