Neuropsychiatric Diagnoses after Montelukast Initiation

JAMA Network: Published on June, 2022

Montelukast, the most widely used leukotriene-modifying agent (LTMA), is a selective leukotriene receptor antagonist and is currently indicated for prophylactic and chronic treatment of asthma, relief of symptoms of allergic rhinitis, and acute prevention of exercise-induced bronchoconstriction.

This propensity score–matched cohort study sought to determine the association between montelukast initiation and 1-year incidence rates of neuropsychiatric diagnosis.

TAKE-HOME MESSAGE

Question: Is montelukast associated with adverse neuropsychiatric outcomes?

Findings: In this cohort study of electronic health records for 72 490 patients with asthma and 82 456 patients with allergic rhinitis, montelukast was associated with higher odds of incident neuropsychiatric outcomes, including anxiety and insomnia.

Specifically, patients with asthma exposed to montelukast had increased odds of being diagnosed with anxiety, and patients with allergic rhinitis exposed to montelukast had increased odds of being diagnosed with insomnia.

Meaning: Providers and patients should be aware of these possible side effects when initiating this leukotriene-modifying agent.

These findings suggest that clinicians should consider monitoring potential adverse mental health symptoms during montelukast treatment, particularly in individuals with a history of mental health or sleep problems.

Inform patients of these adverse reactions at the time of prescribing montelukast, and review within one month of initiation and regularly thereafter.

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Abstract

IMPORTANCE

The evidence base for the association between montelukast and adverse neuropsychiatric outcomes is mixed and inconclusive. Several methodological limitations have been identified in the evidence base on the safety of montelukast in observational studies.

OBJECTIVE

To investigate the association between new montelukast exposure and 1-year incident neuropsychiatric diagnoses with improved precision and control for baseline confounders.

DESIGN, SETTING, AND PARTICIPANTS

This propensity score-matched cohort study was conducted using electronic health records from 2015 to 2019 in the TriNetX Analytics Network patient repository of more than 51 million patients from 56 health care organizations, mainly in the US. Included patients were those aged 15 to 64 years at index prescription for montelukast or for control prescription who had a history of asthma or allergic rhinitis. After propensity score matching for various baseline confounders, including comorbidities and dispensed prescription medicines, we included 154 946 patients, of whom 77 473 individuals were exposed to montelukast. Patients were followed up for 12 months. Data were analyzed from June through November 2021.

EXPOSURES

New dispensed prescription for leukotriene receptor antagonist montelukast or control medication.

MAIN OUTCOMES AND MEASURES

Incident neuropsychiatric diagnoses at 12 months identified using International Statistical Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes.

RESULTS

There were 72 490 patients with asthma (44 726 [61.7%] women; mean [SD] age at index prescription, 35 [15] years) and 82 456 patients with allergic rhinitis (54 172 [65.7%] women; mean [SD] age at index prescription, 40 [14] years). In patients exposed to montelukast, the odds ratio [OR] for any incident neuropsychiatric outcome was 1.11) in patients with asthma and 1.07 in patients with allergic rhinitis compared with patients who were unexposed. The highest OR was for anxiety disorders among patients with asthma exposed to montelukast and insomnia among patients with allergic rhinitis exposed to montelukast.

CONCLUSIONS AND RELEVANCE

This study found that patients with asthma or allergic rhinitis had increased odds of adverse neuropsychiatric outcomes after montelukast initiation. These findings suggest that clinicians should consider monitoring potential adverse mental health symptoms during montelukast treatment, particularly in individuals with a history of mental health or sleep problems.

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