Neuropsychiatric Events following Montelukast Use

Project Title Neuropsychiatric Events following Montelukast Use
Date Posted
Monday, April 22, 2019
Project ID
cder_mpl1r_wp077
Status
Complete
Deliverables
Sentinel Modular Program Report: Neuropsychiatric Adverse Events following Montelukast Use - Report 1
Sentinel Modular Program Report: Neuropsychiatric Adverse Events following Montelukast Use - Report 2
Related Links
Neuropsychiatric Events following Montelukast Use: A Propensity Score Matched Analysis
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.

Medical Product
inhaled corticosteroid
montelukast
nasal corticosteroid
zafirlukast
Health Outcome
neuropsychiatric event
psychotropic medication use
suicide
Time Period
January 1, 2000 - September 30, 2015
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER
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