Neuropsychiatric Events following Montelukast Use: A Propensity Score Matched Analysis

Project Title Neuropsychiatric Events following Montelukast Use: A Propensity Score Matched Analysis
Date Posted
Friday, September 27, 2019
Project ID
cder_mpl2r_wp010, cder_mpl2p_wp014
Status
Complete
Deliverables
Related Links
Description

In this request, we identified individuals with asthma and without chronic obstructive pulmonary disease (COPD) who were dispensed either montelukast or inhaled corticosteroids (ICS) in the Sentinel Distributed Database (SDD), and we examined the association between montelukast versus ICS use and neuropsychiatric events. The request includes three reports:

  • Report 1: We examined the association between montelukast versus ICS use and three outcomes: inpatient depressive disorder, outpatient depressive disorder, and self-harm.
  • Report 2: We examined the association between montelukast versus ICS use and suicide.
  • Report 3: We described rates of mortality among montelukast users and ICS users. Data between January 1, 2000 to September 30, 2015 from 17 Data Partners contributing to the SDD were included in this report.

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

Medical Product
montelukast
Health Outcome
inpatient depressive disorder
outpatient depressive disorder
self-harm
suicide
Population / Cohort
Individuals 6 years of age and older
Time Period
January 1, 2000 - September 30, 2015
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER