Neuropsychiatric Events following Montelukast Use: A Propensity Score Matched Analysis

Project Title Neuropsychiatric Events following Montelukast Use: A Propensity Score Matched Analysis
Date Posted
Monday, August 19, 2019
Project ID
cder_mpl2r_wp010, cder_mpl2p_wp014
Status
In progress
Deliverables
Related Links
Description

This analysis compares the rate of four neuropsychiatric events (inpatient depressive disorder, outpatient depressive disorder, self-harm, and suicide) and describes all-cause mortality in patients with asthma and without chronic obstructive pulmonary disorder (COPD) dispensed montelukast compared to patients dispensed inhaled corticosteroids (ICS).

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