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

Montelukast prescribing information includes a Boxed Warning issued in March 2020 for neuropsychiatric adverse events. A previous study in the Sentinel System in patients with asthma from 2000 to 2015 showed no increased risk of intentional self-harm (ISH) measured using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes in patients dispensed montelukast vs inhaled corticosteroids (ICS). An analysis was performed in Sentinel to examine ISH events following montelukast or ICS use using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes, which may have better accuracy than ICD-9-CM for capturing suicide attempts.

The results of this analysis were presented at the American Academy of Child & Adolescent Psychiatry (AACP's) annual meeting on October 28, 2023. Please find the related abstract for the presentation here.