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Neuropsychiatric Events Following Montelukast Use: A Propensity Score Matched Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
montelukast
Health Outcome(s)
inpatient depressive disorder
outpatient depressive disorder
self-harm
suicide
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 suicide.
  • Report 2: We described rates of mortality among montelukast users and ICS users.
  • Report 3: We examined the association between montelukast versus ICS use and three outcomes: inpatient depressive disorder, outpatient depressive disorder, and self-harm.

Data between January 1, 2000 and September 30, 2015 were included in these reports; Reports 1 and 2 contain data from 6 Data Partners contributing to the SDD, and Report 3 contains data from 16 Data Partners contributing to the SDD.

The analytic packages associated with this analysis can be found externally in Sentinel's Git Repository located here: Package 1, Package 2. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

Deliverables (5)
Neuropsychiatric Events Following Montelukast Use: A Propensity Score Matched Analysis, Report 1 Neuropsychiatric Events Following Montelukast Use: A Propensity Score Matched Analysis, Report 2 Neuropsychiatric Events Following Montelukast Use: A Propensity Score Matched Analysis, Report 3 Sentinel Analytic Package: Neuropsychiatric Events Following Montelukast Use: A Propensity Score Matched Analysis, Package 1 Sentinel Analytic Package: Neuropsychiatric Events Following Montelukast Use: A Propensity Score Matched Analysis, Package 2
Additional Details
FDA Center
CDER
Time Period
January 1, 2000 - September 30, 2015
Analysis Type
Retrospective Inferential
Population / Cohort
Individuals 6 years of age and older
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Neuropsychiatric Events Following Montelukast Use
Inpatient Depressive Disorder Algorithm Defined in "Neuropsychiatric Events Following Montelukast Use: A Propensity Score Matched Analysis"
Outpatient Depressive Disorder Algorithm Defined in "Neuropsychiatric Events Following Montelukast Use: A Propensity Score Matched Analysis"
Self-Harm Algorithms Defined in "Neuropsychiatric Events Following Montelukast Use: A Propensity Score Matched Analysis"
Suicide Algorithm Defined in "Neuropsychiatric Events Following Montelukast Use: A Propensity Score Matched Analysis"
Joint Meeting of the Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee: Singulair and Neuropsychiatric Events
FDA Safety Communication: FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis
Risk of Psychiatric Adverse Events among Montelukast Users
ICPE 2020: Risk of Neuropsychiatric Adverse Events among Montelukast Users
Sentinel Drug Assessment: Singulair (Montelukast) & Inpatient Depressive Disorder, Outpatient Depressive Disorder, Self-Harm, and Suicide