Changes in the Use of Montelukast for Asthma After a US Food and Drug Administration Boxed Warning
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By
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Hariharan Shanmugam
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Aaron S. Kesselheim
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Ian T. T. Liu
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William B. Feldman
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Benjamin N. Rome
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May 22, 2026
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Clinical Scorecard: Impact of FDA Boxed Warning on Montelukast Prescribing Patterns for Asthma Management
At a Glance
| Category | Detail |
|---|
| Condition | Asthma and allergic rhinitis |
| Key Mechanisms | Leukotriene receptor antagonist |
| Target Population | Individuals older than age 6 with asthma |
| Care Setting | Outpatient settings using national commercial claims data |
Key Highlights
- Montelukast is associated with potential neuropsychiatric adverse effects.
- FDA added a boxed warning for montelukast in April 2020.
- Impact of boxed warnings on prescription rates can vary.
- Study used data from October 2017 to December 2022.
- Incidence and prevalence of montelukast use were primary outcomes.
Guideline-Based Recommendations
Diagnosis
- ICD-10 diagnosis code for asthma required for inclusion.
Management
- Montelukast use should be determined on a case-by-case basis.
Monitoring & Follow-up
- Monitor for neuropsychiatric adverse effects in patients.
Risks
- Potential risks include depression, aggressive behavior, and suicidal ideation.
Patient & Prescribing Data
Patients with asthma aged 6 years and older.
Montelukast prescriptions were analyzed before and after the boxed warning.
Clinical Best Practices
- Assess asthma severity using established criteria.
- Consider alternative therapies if montelukast is not effective.
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