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May 24, 2026JAMA Network OpenOpen Access

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

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Authors

HSHariharan ShanmugamAKAaron S. KesselheimILIan T. T. Liu

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Overview

Serial cross-sectional study shows decreased montelukast prescriptions after FDA warning in asthma patients, indicating treatment changes.

Key Points

  • This study aims to evaluate the impact of an FDA boxed warning on montelukast prescription rates for asthma treatment.
  • Used a national commercial insurance claims database for analysis.
  • Included individuals aged 6 years and older diagnosed with asthma from October 2017 to December 2022.
  • Employed interrupted time series analysis with segmented regression models.
  • Monthly incidence of new montelukast prescriptions decreased by 1.7 per 1000 (95% CI, -2.2 to -1.3).
  • Monthly prevalence of montelukast use declined by 0.9 per 1000 (95% CI, -1.1 to -0.6) post-warning.
  • The decrease in montelukast use was consistent across all age groups and asthma severity levels.

Cite This Study

Shanmugam et al. (2026) studied this question.

synapsesocial.com/papers/6a1295cf48a0ea1665672283https://doi.org/10.1001/jamanetworkopen.2026.14274
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