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Neuropsychiatric Events following Montelukast Use

Basic Details
Date Posted
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.

Deliverables (2)
Sentinel Modular Program Report: Neuropsychiatric Adverse Events following Montelukast Use - Report 1 Sentinel Modular Program Report: Neuropsychiatric Adverse Events following Montelukast Use - Report 2
Additional Details
FDA Center
CDER
Time Period
January 1, 2000 - September 30, 2015
Analysis Type
Descriptive
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: Singulair (Montelukast) & Neuropsychiatric Adverse Events Consisting of: Inpatient Depressive Disorder, Outpatient Depressive Disorder, Self-Harm, and Suicide