Montelukast and Neuropsychiatric Events in Children with Asthma: A Nested Case-Control Study
S Dresden Glockler-Lauf1, Yaron Finkelstein2, Jingqin Zhu3
1Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario.
Insights
Children with asthma prescribed montelukast had nearly double the odds of experiencing a new-onset neuropsychiatric event. This study highlights a potential association between montelukast and adverse neuropsychiatric events in pediatric asthma patients.
Area of Science:
- Pediatric Asthma Research
- Neuropsychiatric Event Analysis
- Pharmacovigilance in Children
Background:
- Asthma is a common chronic respiratory disease in children.
- Montelukast is a widely prescribed medication for asthma management.
- Neuropsychiatric events are a potential concern in pediatric populations.
Purpose of the Study:
- To investigate the association between montelukast prescription and neuropsychiatric events in children with asthma.
- To determine if there is a statistically significant link between montelukast use and the occurrence of neuropsychiatric events.
- To provide evidence for clinicians regarding potential risks associated with montelukast in pediatric asthma patients.
Main Methods:
- A matched, nested case-control study design was employed.
- Data were sourced from a cohort of children aged 5-18 years with physician-diagnosed asthma in Ontario, Canada (2004-2015).
- Cases were defined by hospitalization or emergency department visits for neuropsychiatric events, matched to controls based on birth year, asthma diagnosis year, and sex. Conditional logistic regression was used.
Main Results:
- The study included 898 cases and 3,497 matched controls.
- Children experiencing new-onset neuropsychiatric events had nearly double the odds of having been prescribed montelukast (OR 1.91, 95% CI 1.15-3.18).
- Anxiety and sleep disturbances were the most common neuropsychiatric events observed in cases.
Conclusions:
- Children with asthma who experienced new-onset neuropsychiatric events showed a significantly higher likelihood of prior montelukast prescription.
- Clinicians should consider this association when prescribing montelukast to children with asthma.
- Awareness of this potential link can inform prescribing practices and guide clinical follow-up for pediatric patients.
Objective:
To examine the association between montelukast prescription and neuropsychiatric events in children with asthma.
Study Design:
A matched, nested case-control design was used to identify cases and controls from a cohort of children aged 5-18 years with physician-diagnosed asthma from 2004 to 2015, in Ontario, Canada, prescribed an asthma maintenance medication. Cases were children with a hospitalization or emergency department visit for a neuropsychiatric event. Cases were matched to up to 4 controls on birth year, year of asthma diagnosis, and sex. The exposures were dispensed prescriptions for montelukast (yes/no) and number of dispensed montelukast prescriptions in the year before the index date. Conditional logistic regression was used to measure the unadjusted OR and aOR and 95% CIs for montelukast prescription and neuropsychiatric events. Covariates in the adjusted model included sociodemographic factors and measures of asthma severity.
Results:
In total, 898 cases with a neuropsychiatric event and 3497 matched controls were included. Children who experienced a new-onset neuropsychiatric event had nearly 2 times the odds of having been prescribed montelukast, compared with controls (OR 1.91, 95% CI 1.15-3.18; P = .01). Most cases presented for anxiety (48.6%) and/or sleep disturbance (26.1%).
Conclusions:
Children with asthma who experienced a new-onset neuropsychiatric event had nearly twice the odds of having been prescribed montelukast in the year before their event. Clinicians should be aware of the association between montelukast and neuropsychiatric events in children with asthma, to inform prescribing practices and clinical follow-up.
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