Shanmugam H, Kesselheim AS, Liu ITT et al. JAMA Netw Open. 2026;9(5):e2614274. doi:10.1001/jamanetworkopen.2026.14274
Key Points
- Question Did the use of montelukast to treat asthma change after an US Food and Drug Administration (FDA) boxed warning was announced in March 2020?
- Findings In this cross-sectional study using national monthly cohorts of up to 614 637 patients with asthma from a national commercial claims dataset, the use of montelukast decreased after implementation of an FDA boxed warning.
- Meaning These findings suggest that treatment patterns for patients with asthma changed after an FDA boxed warning.
Abstract
Importance In March 2020, the US Food and Drug Administration (FDA) issued a boxed warning for montelukast amid reports of neuropsychiatric adverse effects.


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