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Intentional Self-Harm Following Montelukast Use in Patients with Asthma: An Updated Analysis Using ICD-10-CM Coding

    Basic Details
    Date Posted
    Medical Product
    inhaled corticosteroids
    Health Outcome(s)
    intentional self-harm

    This analysis describes the characteristics of patients dispensed montelukast or inhaled corticosteroids and evaluates the subsequent risk of intentional self-harm identified using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis codes in the Sentinel Distributed Database. This analysis was conducted as an update to a previous Sentinel study that used International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes to identify intentional self-harm events. The study period includes data from October 1, 2015 to June 30, 2022. We distributed this request to six Sentinel Data Partners on December 21, 2022.

    The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

    Additional Details
    FDA Center
    Time Period
    October 1, 2015 – June 30, 2022
    Analysis Type
    Retrospective Inferential
    Population / Cohort
    Individuals 10 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)