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Ischemic Colitis Following Alosetron Use: A Descriptive Analysis

    Basic Details
    Date Posted
    Wednesday, May 24, 2023
    Medical Product
    Health Outcome(s)
    ischemic colitis

    The goals of this analysis were to identify new users of alosetron and eluxadoline in the Sentinel Distributed Database (SDD) and to examine ischemic colitis events among those individuals using different definitions of the outcome as sensitivity analyses. The study period includes data from January 1, 2016 to July 1, 2020. We distributed this request to six Sentinel Data Partners on February 8, 2022.

    Additional Details
    FDA Center
    Time Period
    January 1, 2016 - July 1, 2020
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)