Changes in the Use of Montelukast for Asthma After a US Food and Drug Administration Boxed Warning - Scorecard - MDSpire
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Impact of FDA Boxed Warning on Montelukast Prescribing Patterns for Asthma Management

  • By

  • Hariharan Shanmugam

  • Aaron S. Kesselheim

  • Ian T. T. Liu

  • William B. Feldman

  • Benjamin N. Rome

  • May 22, 2026

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Clinical Scorecard: Impact of FDA Boxed Warning on Montelukast Prescribing Patterns for Asthma Management

At a Glance

CategoryDetail
ConditionAsthma and allergic rhinitis
Key MechanismsLeukotriene receptor antagonist
Target PopulationIndividuals older than age 6 with asthma
Care SettingOutpatient 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.

Related Resources & Content

Original Source(s)

Changes in the Use of Montelukast for Asthma After a US Food and Drug Administration Boxed Warning

  • by Hariharan Shanmugam, Aaron S. Kesselheim, Ian T. T. Liu, William B. Feldman, Benjamin N. Rome

  • May 22, 2026

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