title: Patterns in spontaneous adverse event reporting among branded and generic antiepileptic drugs.
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 (<1%). These results suggest that pharmacovigilance stakeholders should act to promote more detailed reporting practices.
authors: Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, USA; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts, USA; Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, Maryland, USA.
authors: J
authors: J
authors: Bohn
authors: C
authors: C
authors: Kortepeter
authors: M
authors: M
authors: Muñoz
authors: K
authors: K
authors: Simms
authors: S
authors: S
authors: Montenegro
authors: G
authors: G
authors: Dal Pan
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000639:trends*; D000927:Anticonvulsants / Q000009:adverse effects*; D004345:Drug Industry / Q000639:trends*; D011307:Drug Prescriptions; D017723:Drug Utilization Review / Q000639:trends; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D016568:Drugs, Generic / Q000009:adverse effects*; D006801:Humans; D060735:Pharmacovigilance; D010818:Practice Patterns, Physicians' / Q000639:trends*; D013997:Time Factors; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000639:trends*
chemical_list: D000927:Anticonvulsants; D016568:Drugs, Generic