TabsDetailsBasic DetailsDate Posted: Monday, April 22, 2019Status: CompleteMedical Product: inhaled corticosteroid, montelukast, nasal corticosteroid, zafirlukastHealth Outcome(s): neuropsychiatric eventpsychotropic medication usesuicideDescription: 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. Read More Deliverables (2)Sentinel Modular Program Report: Neuropsychiatric Adverse Events following Montelukast Use - Report 1Sentinel Modular Program Report: Neuropsychiatric Adverse Events following Montelukast Use - Report 2Additional InformationAdditional DetailsFDA Center: CDERTime Period: January 1, 2000 - September 30, 2015Study Type: Modular ProgramAssessment Type: Exploratory AnalysesData Sources: Sentinel Distributed Database (SDD)Related Links: Neuropsychiatric Events following Montelukast Use: A Propensity Score Matched Analysis