Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs
Ning Cheng,
Md. Motiur Rahman,
Yasser Alatawi,
Jingjing Qian,
Peggy L. Peissig,
Richard L. Berg,
C. David Page and
Richard A. Hansen ()
Additional contact information
Ning Cheng: Auburn University
Md. Motiur Rahman: Auburn University
Yasser Alatawi: Auburn University
Jingjing Qian: Auburn University
Peggy L. Peissig: Biomedical Informatics Research Center, Marshfield Clinic Research Institute
Richard L. Berg: Biomedical Informatics Research Center, Marshfield Clinic Research Institute
C. David Page: University of Wisconsin
Richard A. Hansen: Auburn University
Drug Safety, 2018, vol. 41, issue 4, No 5, 363-376
Abstract:
Abstract Introduction Several different types of drugs acting on the central nervous system (CNS) have previously been associated with an increased risk of suicide and suicidal ideation (broadly referred to as suicide). However, a differential association between brand and generic CNS drugs and suicide has not been reported. Objectives This study compares suicide adverse event rates for brand versus generic CNS drugs using multiple sources of data. Methods Selected examples of CNS drugs (sertraline, gabapentin, zolpidem, and methylphenidate) were evaluated via the US FDA Adverse Event Reporting System (FAERS) for a hypothesis-generating study, and then via administrative claims and electronic health record (EHR) data for a more rigorous retrospective cohort study. Disproportionality analyses with reporting odds ratios and 95% confidence intervals (CIs) were used in the FAERS analyses to quantify the association between each drug and reported suicide. For the cohort studies, Cox proportional hazards models were used, controlling for demographic and clinical characteristics as well as the background risk of suicide in the insured population. Results The FAERS analyses found significantly lower suicide reporting rates for brands compared with generics for all four studied products (Breslow–Day P
Date: 2018
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DOI: 10.1007/s40264-017-0624-0
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