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

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

  • 0 min

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Clinical Report: Impact of FDA Boxed Warning on Montelukast Prescribing Patterns

Overview

This study evaluates the impact of the FDA's boxed warning on montelukast prescribing patterns for asthma management. Following the warning's implementation in April 2020, changes in both the incidence and prevalence of montelukast use were analyzed using national claims data.

Background

Montelukast is widely used for asthma and allergic rhinitis, but concerns regarding neuropsychiatric side effects have led to increased scrutiny. The FDA's boxed warning aims to inform healthcare providers and patients about these risks, potentially influencing prescribing behaviors. Understanding the effects of such warnings is crucial for optimizing asthma management while ensuring patient safety.

Data Highlights

Revise to summarize key findings instead of stating no numerical data was provided.

Key Findings

  • The FDA added a boxed warning for montelukast in April 2020 regarding potential neuropsychiatric effects.
  • Prior studies indicate mixed impacts of boxed warnings on prescription rates across different drug classes.
  • The study utilized national claims data from October 2017 to December 2022 to assess montelukast use.
  • Prevalent use was defined as the proportion of asthma patients with a filled montelukast prescription each month.
  • Incident use was defined as new prescriptions filled by asthma patients who had not used montelukast in the prior year.

Clinical Implications

Healthcare providers should be aware of the FDA's boxed warning when prescribing montelukast, particularly for patients with a history of neuropsychiatric issues. Ongoing evaluation of the benefits and risks of montelukast is essential, especially in pediatric populations where adverse effects may significantly impact daily life.

Conclusion

The implementation of the FDA's boxed warning for montelukast may have significant implications for its prescribing patterns in asthma management. Further research is needed to fully understand the long-term effects of this warning on patient care.

Related Resources & Content

  1. JAMA Network Open, 2023 -- The Unfinished Science of Boxed Drug Warnings
  2. Drug Safety, 2022 -- Characterizing Nightmares Associated with Montelukast: Insights from VigiBase Data
  3. Drug Safety, 2019 -- Investigation of Safety Signals for Pediatric Asthma Medications Utilizing the EudraVigilance Spontaneous Reporting Database
  4. Drugs - Real World Outcomes, 2022 -- Incidence of Adverse Drug Reactions from Common Asthma Treatments in Hospitalized Pediatric Patients in the US, 2000–2016
  5. 2026 GINA Strategy Report - Global Initiative for Asthma - GINA
  6. JAMA Pediatrics, 2023 -- Montelukast Use and the Risk of Neuropsychiatric Adverse Events in Children
  7. 2025 GINA Summary Guide
  8. 2026 GINA Strategy Report - Global Initiative for Asthma - GINA
  9. Montelukast Use and the Risk of Neuropsychiatric Adverse Events in Children | Asthma | JAMA Pediatrics | JAMA Network

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