Montelukast and Neuropsychiatric Events in Children With Asthma: A Nested Case-Control Study

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AAP Policy SupplementsSupplements Publish Supplement MultimediaVideo Abstracts Pediatrics On Call Podcast Subscribe Alerts Careers We will not be accepting article comments until November 8, 2021, while our site undergoes major changes. We apologize for the inconvenience. For questions, contact the editorial office. Asthma Montelukast and Neuropsychiatric Events in Children With Asthma: A Nested Case-Control Study Sheeba Kunnel Cherian and Kansas J. Andrew Bird Pediatrics December 2020, 146 (Supplement 4) S371-S372; DOI: https://doi.org/10.1542/peds.2020-023861DDDD Sheeba Kunnel Cherian Kansas CityFind this author on Google ScholarFind this author on PubMedSearch for this author on this siteKansas J. Andrew Bird Dallas, TexasFind this author on Google ScholarFind this author on PubMedSearch for this author on this site ArticleInfo & MetricsComments Download PDF SD Glockler-Lauf, Y Finkelstein, J Zhu, LY Feldman, T To. J Pediatr. 2019;209:176–182.e4PURPOSE OF THE STUDY:To assess the association between montelukast prescription and neuropsychiatric events in children with asthma.STUDY POPULATION:Ontario children aged 5–18 years with an index neuropsychiatric event between April 1, 2004, and March 31, 2016, were identified as cases within a study cohort of children with physician-diagnosed asthma prescribed an asthma maintenance medication. Patients with pre-existing mental health conditions or a dispensed prescription for zafirlukast were excluded.METHODS:Each case was matched based on sex, asthma diagnosis date, and birthdate to a maximum of four control patients without a neuropsychiatric event from the same study cohort. Data regarding montelukast exposure was collected with exposure defined by at least one dispensed prescription for montelukast in the year prior to the index neuropsychiatric event. The number of dispensed prescriptions for montelukast was also assessed. The primary outcome was the first neuropsychiatric event following asthma diagnosis, with events categorized as schizophrenia, anxiety, sleep disturbance, mood and personality disorders, or agitation. Measures of asthma severity including number of dispensed prescriptions for asthma maintenance medications and systemic corticosteroids, hospitalizations, and emergency department (ED) visits were assessed as covariates. Information from an Ontario census-based data tool and health authority network was used to control for geographical and sociodemographic factors.RESULTS:898 children with asthma with an index neuropsychiatric event were identified. 3497 controls were matched to these cases. The most common presentation of neuropsychiatric events was anxiety (48.6%) followed by sleep disturbance (26.1%). Exposure to montelukast was more common in the cases compared with the controls (cases: 8.1%, controls: 2.1%, P < .001). Cases also had significantly more ED visits and hospitalizations for asthma, number of asthma maintenance medication prescriptions, and a greater proportion of dispensed prescriptions for systemic corticosteroids. Conditional logistic regression was statistically significant and showed that children with at least one dispensed prescription for montelukast had almost 2 times increased odds of a neuropsychiatric event after controlling for sociodemographic factors, number of asthma maintenance medication prescriptions, systemic corticosteroid prescriptions, and number of hospitalizations and ED visits for asthma.CONCLUSIONS:Exposure to montelukast was significantly associated with a nearly twofold increase in the odds of neuropsychiatric events compared with other asthma maintenance medications when controlled for sociodemographic factors and measures of asthma severity.REVIEWER COMMENTS:Montelukast is a leukotriene receptor antagonist indicated for use in the management of asthma, exercise-induced bronchoconstriction, and allergic rhinitis. In March 2020, the US Food and Drug Administration issued a “black box warning” on montelukast, thereby strengthening existing warnings regarding behavior and mood-related changes. Current recommendations by the Food and Drug Administration include consideration of risks and benefits before prescribing montelukast for asthma and reservation of montelukast use for allergic rhinitis in patients not tolerating or not treated effectively by alternative therapy. The pathophysiology underlying the potential neuropsychiatric effects of montelukast remains poorly understood and warrants further study.Copyright © 2020 by the American Academy of Pediatrics PreviousNext Back to top Advertising Disclaimer » In this issue Pediatrics Vol. 146, Issue Supplement 4 1 Dec 2020 Table of ContentsIndex by author View this article with LENS PreviousNext Email Article Thank you for your interest in spreading the word on American Academy of Pediatrics.NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address. Your Email * Your Name * Send To * Enter multiple addresses on separate lines or separate them with commas. 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Andrew Bird Pediatrics Dec 2020, 146 (Supplement 4) S371-S372; DOI: 10.1542/peds.2020-023861DDDD Citation Manager Formats BibTeXBookendsEasyBibEndNote (tagged)EndNote 8 (xml)MedlarsMendeleyPapersRefWorks TaggedRef ManagerRISZotero Share Montelukast and Neuropsychiatric Events in Children With Asthma: A Nested Case-Control Study Sheeba Kunnel Cherian, Kansas J. Andrew Bird Pediatrics Dec 2020, 146 (Supplement 4) S371-S372; DOI: 10.1542/peds.2020-023861DDDD Share This Article: Copy Print Download PDF Insight Alerts Table of Contents Jump to section ArticlePURPOSE OF THE STUDY:STUDY POPULATION:METHODS:RESULTS:CONCLUSIONS:REVIEWER COMMENTS:Info & MetricsComments Related ArticlesNo related articles found.Google Scholar Cited By...No citing articles found.Google Scholar More in this TOC SectionAsthma Prevalence of Continuous Pulse Oximetry Monitoring in Hospitalized Children With Bronchiolitis Not Requiring Supplemental Oxygen Lung Computational Models and the Role of the Small Airways in Asthma Increased Capsaicin Sensitivity in Patients With Severe Asthma Is Associated With Worse Clinical Outcome Show more Asthma Medical Therapies Tiotropium is Efficacious in 6 to 17 Year-Olds With Asthma, Independent of T2 Phenotype Dupilumab Efficacy in Patients With Uncontrolled, Moderate-to-Severe Allergic Asthma Prescribing Emergency Oral Steroids in Asthma Clinics [published online ahead of print June 11, 2019] Show more Medical Therapies Similar Articles Journal Info Editorial Board Editorial Policies Overview Licensing Information Authors/Reviewers Author Guidelines Submit My Manuscript Open Access Reviewer Guidelines Librarians Institutional Subscriptions Usage Stats Support Contact Us Subscribe Resources Media Kit About International Access Terms of Use Privacy Statement FAQ AAP.org shopAAP Follow American Academy of Pediatrics on Instagram Visit American Academy of Pediatrics on Facebook Follow American Academy of Pediatrics on Twitter Follow American Academy of Pediatrics on Youtube RSS © 2021 American Academy of Pediatrics