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Neuropsychiatric Events following Montelukast Use

    Basic Details
    Date Posted
    Medical Product
    inhaled corticosteroid
    nasal corticosteroid
    Health Outcome(s)
    neuropsychiatric event
    psychotropic medication use

    The goal of this request was to estimate the number of neuropsychiatric events, including suicide, and psychotropic medication use among patients using montelukast in the Sentinel Distributed Database (SDD). This request has two reports:

    • Report 1 contains estimates of the number of new users of montelukast, zafirlukast, inhaled corticosteroids, and nasal corticosteroids in the SDD. 
    • Report 2 contains estimates of neuropsychiatric events and psychotropic medication use among patients using montelukast, zafirlukast, inhaled corticosteroids, or nasal corticosteroids in the SDD.

    Data from January 1, 2000 to September 30, 2015 from 16 Data Partners contributing to the SDD were included in this request. This request was distributed to Data Partners on March 22, 2018.

    Additional Details
    FDA Center
    Time Period
    January 1, 2000 - September 30, 2015
    Analysis Type
    Data Sources
    Sentinel Distributed Database (SDD)