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

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Montelukast is a leukotriene receptor antagonist used for asthma, but concerns about neuropsychiatric effects have emerged since its approval.
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In March 2020, the FDA added a boxed warning to montelukast, advising case-by-case use for asthma and restricting its use for allergic rhinitis.
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Prior studies show mixed impacts of boxed warnings on prescription rates, with some leading to reduced use while others had no measurable effect.
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This study analyzed changes in montelukast prescribing patterns after the FDA boxed warning using national claims data from 2017 to 2022.
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The analysis included stratified assessments by age and asthma severity to evaluate the impact of the boxed warning on montelukast use.

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