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

To measure changes in montelukast use for asthma management from March 2020 to December 2022 after the implementation of the FDA boxed warning.

Key Findings:
  • The FDA added a boxed warning for montelukast in March 2020 regarding potential neuropsychiatric adverse effects, which may have influenced prescribing patterns.
  • Prior studies show mixed impacts of boxed warnings on prescription rates, with some leading to decreased use and others showing no significant change.
  • The study aimed to analyze the effect of the boxed warning on montelukast prescribing patterns, hypothesizing a decrease in use.
Interpretation:

The study assesses the implications of the FDA's boxed warning on montelukast use, which may significantly influence asthma management practices.

Limitations:
  • The study is retrospective and relies on claims data, which may not capture all clinical nuances, including potential missing data.
  • Potential confounding factors, such as the COVID-19 pandemic, were considered but may still affect results.
Conclusion:

The study provides insights into how regulatory warnings can impact medication prescribing patterns in asthma management, highlighting the need for ongoing monitoring of prescribing behaviors.

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