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Patterns in spontaneous adverse event reporting among branded and generic antiepileptic drugs
Author(s) -
Bohn J,
Kortepeter C,
Muñoz M,
Simms K,
Montenegro S,
Pan G Dal
Publication year - 2015
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.81
Subject(s) - adverse event reporting system , pharmacovigilance , adverse effect , brand names , food and drug administration , medicine , suspect , medical prescription , event (particle physics) , product (mathematics) , generic drug , business , pharmacology , drug , marketing , psychology , physics , geometry , mathematics , criminology , quantum mechanics
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 (<1%). These results suggest that pharmacovigilance stakeholders should act to promote more detailed reporting practices.