Neuropsychiatric Events following Montelukast Use

    Basic Details
    Date Posted
    Monday, April 22, 2019
    Status
    Complete
    Medical Product
    inhaled corticosteroid
    montelukast
    nasal corticosteroid
    zafirlukast
    Health Outcome(s)
    neuropsychiatric event
    psychotropic medication use
    suicide
    Description

    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
    CDER
    Time Period
    January 1, 2000 - September 30, 2015
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Data Sources
    Sentinel Distributed Database (SDD)