Antipsychotics and Stroke

    Basic Details
    Date Posted
    Wednesday, November 1, 2017
    Status
    Complete
    Medical Product
    aripiprazole
    atypical antipsychotic
    haloperidol
    olanzapine
    olanzapine/fluoxetine
    quetiapine
    risperidone
    selective serotonin reuptake inhibitor (SSRI)
    typical antipsychotic
    Health Outcome(s)
    intracranial hemorrhage
    ischemic stroke
    Description

    This report contains estimates of atypical and typical antipsychotics and Selective Serotonin Reuptake Inhibitors (SSRIs) users with subsequent ischemic stroke or intracranial hemorrhage. This report also contains baseline characteristics of atypical and typical antipsychotics users with and without prior SSRI use. The query was run against the Sentinel Distributed Database (SDD) for the time period from January 1, 2001 to September 30, 2015. The request was distributed to 16 Data Partners on December 23, 2016.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2001 - September 30, 2015
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)