Risk of Hospitalized Depression and Intentional Self-harm with Brand and Authorized Generic Sertraline

    Basic Details
    Date
    Monday, October 4, 2021
    Type
    Publication
    Description

    Recent suggestions of therapeutic inequivalence of brand and generic sertraline have raised concerns about disproportionately higher adverse events among generic users. To assess the impact of confounding in a comparison of the risks of worsening depression and intentional self-harm (ISH) between users of brand name sertraline and its pharmaceutically equivalent authorized generic (AG).

     

    Author(s)

    Dinci D. Pennap, Richard S. Swain, Emily C. Welch, Justin Bohn, Jennifer G. Lyons, Sarah Dutcher, Andrew D. Mosholder

     

    Corresponding Author

    Dinci D. Pennap; Division of Epidemiology I, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA
    Email: dinci.pennap@fda.hhs.gov