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Singulair (Montelukast) & Neuropsychiatric Adverse Events Consisting of: Inpatient Depressive Disorder, Outpatient Depressive Disorder, Self-Harm, and Suicide

Basic Details
Status
Complete
Last Updated
Thursday, March 5, 2020
Health Outcome(s)
inpatient depressive disorder
outpatient depressive disorder
self-harm
suicide
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

FDA presented a Sentinel study at a 2019 Advisory Committee of the risk of mental health side effects with montelukast compared to inhaled corticosteroids (ICS). In this study, FDA did not identify an elevated risk of hospitalized and treated outpatient depressive disorders, self-harm, and suicides among patients aged 6 years and older with asthma using montelukast compared to ICS. FDA also found no evidence that the risk of mental health side effects was modified by the 2008 FDA Early Communication. However, after reviewing the available information and convening a panel of outside experts, FDA strengthened the existing warnings about serious behavior and mood-related changes with montelukast by requiring a Boxed Warning because the benefits of montelukast may not outweigh the risks in patients with mild symptoms who could be adequately treated with other medicines.

Analytic Code Link(s) (1)
Neuropsychiatric Events Following Montelukast Use: A Propensity Score Matched Analysis
Result(s) (2)
Neuropsychiatric Events Following Montelukast Use: A Propensity Score Matched Analysis Neuropsychiatric Events following Montelukast Use
Regulatory Link(s) (2)
Advisory Committee Materials Drug Safety Communication