Antidepressant Use and Bleeding Events

    Basic Details
    Date Posted
    Friday, May 20, 2016
    Status
    Complete
    Medical Product
    antidepressant
    selective serotonin reuptake inhibitor (SSRI)
    serotonin-norepinephrine reuptake inhibitor (SNRI)
    tricyclic
    Health Outcome(s)
    bleeding event
    gastrointestinal hemorrhage
    intracerebral hemorrhage (ICH)
    Description

    Modular program-based one-time assessment of the use of antidepressants (SSRIs, SNRIs, and tricyclics) and risk of bleeding events among members with a pre-existing condition of depression and members with no pre-existing condition requirements. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2009 through December 31, 2011.  Modular programs are adaptable standardized programs. Results were generated using Modular Program 3, version 1.0; click here for more information.  Queries were distributed in February 2012. This report includes data from 18 Data Partners.
     
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    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2009 to December 31, 2011
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)