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Assessing the Risk of Intentional Self-Harm in Montelukast Users: An Updated Sentinel System Analysis Using ICD-10 Coding

    Basic Details

    Montelukast prescribing information includes a Boxed Warning issued in March 2020 regarding neuropsychiatric adverse events. A previous Sentinel System study of asthma patients from 2000 to 2015 did not demonstrate an increased risk of intentional self-harm measured using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes, with montelukast compared to inhaled corticosteroids (ICS).

    Using a new user cohort study design, we examined intentional self-harm events in patients aged ten years and older who were incident users of either montelukast or ICS as monotherapy, with a diagnosis of asthma, between October 1, 2015, to June 30, 2022, in the Sentinel System. We measured intentional self-harm using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes, which may have better accuracy for capturing suicide attempts than ICD-9-CM codes. We used inverse probability of treatment weighting to balance baseline covariates. We performed subgroup analyses by age group, sex, psychiatric history, and pre/post Boxed Warning era and conducted sensitivity analyses varying type of care setting of the outcome and exposure episode gaps.


    Jummai Apata, Jennifer G. Lyons, Marie C. Bradley, Yong Ma, Maria E. Kempner, Ivone Kim, Efe Eworuke, Dinci Pennap, Andrew Mosholder

    Corresponding Author

    Andrew Mosholder, Division of Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA