@article{ref1,
title="Assessing the risk of intentional self-harm in montelukast users: an updated Sentinel System analysis using ICD-10 coding",
journal="Journal of asthma",
year="2023",
author="Apata, Jummai and Lyons, Jennifer G. and Bradley, Marie C. and Ma, Yong and Kempner, Maria E. and Kim, Ivone and Eworuke, Efe and Pennap, Dinci and Mosholder, Andrew",
volume="ePub",
number="ePub",
pages="ePub-ePub",
abstract="BACKGROUND: 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). <br><br>METHODS: Using a new user cohort study design, we examined intentional self-harm events in patients aged 10 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 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. <br><br>RESULTS: Among 752,230 and 724,855 patients in the montelukast and ICS exposure groups, respectively, we found no association between montelukast use and self-harm compared to ICS use [Hazard Ratio (95% Confidence Interval): 0.96 (0.85, 1.08)]. This finding was consistent across all subgroups, and sensitivity analyses. <br><br>CONCLUSION: Our results cannot exclude other neuropsychiatric idiosyncratic reactions to montelukast. Compared to the previous Sentinel study, this study identified about double the rate of self-harm events, suggesting a greater sensitivity of ICD-10 codes for measuring self-harm than ICD-9.<p /> <p>Language: en</p>",
language="en",
issn="0277-0903",
doi="10.1080/02770903.2023.2293064",
url="http://dx.doi.org/10.1080/02770903.2023.2293064"
}