Patterns in spontaneous adverse event reporting among branded and generic antiepileptic drugs

J. Bohn, C. Kortepeter, M. Muñoz, K. Simms, S. Montenegro, G. Dal Pan

Research output: Contribution to journalArticle

Abstract

Spontaneous adverse event reports constitute an important source of information on previously unknown adverse reactions to marketed medicines. However, the dynamics of such reporting following generic introduction are poorly understood. Using adverse event reports on five antiepileptic drugs from the US Food and Drug Administration's Adverse Event Reporting System, we describe temporal trends in adverse event reporting before and after generic introduction, and survey the quality of product-identifying information contained therein. The majority of reports were sent by innovator drug manufacturers while few were sent by generic manufacturers, even when generics accounted for >90% of dispensed prescriptions. We manually reviewed narratives from 2,500 reports and found that the suspect product type (brand or generic) could not be determined in 84% of reports, while generic products (16%) were identified more often than brand-name products (

Original languageEnglish (US)
Pages (from-to)508-517
Number of pages10
JournalClinical Pharmacology and Therapeutics
Volume97
Issue number5
DOIs
StatePublished - May 1 2015
Externally publishedYes

    Fingerprint

ASJC Scopus subject areas

  • Medicine(all)

Cite this