Original Investigation

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

JAMA Network Open 10.1001/jamanetworkopen.2026.14274

May 22, 2026 at 11:00 AM EDT

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Did the use of montelukast to treat asthma change after an US Food and Drug Administration (FDA) boxed warning was announced in March 2020?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.These findings suggest that treatment patterns for patients with asthma changed after an FDA boxed warning.

Corresponding Author: Benjamin N. Rome, MD, MPH, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, 1620 Tremont St, Suite 3030, Boston, MA 02120 (brome@bwh.harvard.edu).

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