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Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs

Author

Listed:
  • 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
    University of Wisconsin)

  • Richard A. Hansen

    (Auburn University)

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

Suggested Citation

  • Ning Cheng & Md. Motiur Rahman & Yasser Alatawi & Jingjing Qian & Peggy L. Peissig & Richard L. Berg & C. David Page & Richard A. Hansen, 2018. "Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs," Drug Safety, Springer, vol. 41(4), pages 363-376, April.
    • Handle: RePEc:spr:drugsa:v:41:y:2018:i:4:d:10.1007_s40264-017-0624-0
    DOI: 10.1007/s40264-017-0624-0
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    References listed on IDEAS

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    1. Geetha Iyer & Sathiya Priya Marimuthu & Jodi B. Segal & Sonal Singh, 2017. "An Algorithm to Identify Generic Drugs in the FDA Adverse Event Reporting System," Drug Safety, Springer, vol. 40(9), pages 799-808, September.
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    Cited by:

    1. Courtney M. Suggs & Robert L. Levin & Andrew D. Mosholder & Richard S. Swain & Liang Zhao, 2018. "Comment on: “Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs”," Drug Safety, Springer, vol. 41(12), pages 1419-1421, December.
    2. Richard A. Hansen & Ning Cheng & Md. Motiur Rahman & Yasser Alatawi & Jingjing Qian & Peggy L. Peissig & Richard L. Berg & C. David Page, 2018. "Authors' Reply to Courtney Suggs and Colleagues’ Comment on: “Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs”," Drug Safety, Springer, vol. 41(12), pages 1423-1424, December.

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    1. Courtney M. Suggs & Robert L. Levin & Andrew D. Mosholder & Richard S. Swain & Liang Zhao, 2018. "Comment on: “Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs”," Drug Safety, Springer, vol. 41(12), pages 1419-1421, December.
    2. Sonal Singh, 2018. "The Safety of Generic Prescription Drugs in the United States," Drug Safety, Springer, vol. 41(4), pages 325-328, April.

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