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Risk of Gastrointestinal Hypomotility, Constipation, or GI Dysmotility with Serious Complications and Intentional Self-Harm in Individuals with Migraine Following Use of CGRP Inhibitors: A Propensity Score Matched Analysis

    Basic Details
    Date Posted
    Status
    In progress
    Medical Product
    calcitonin gene-related peptide (CGRP) Inhibitors
    Health Outcome(s)
    constipation or GI dysmotility with serious complications and intentional self-harm
    gastrointestinal hypomotility
    Description

    This analysis evaluated the association between calcitonin gene-related peptide (CGRP) inhibitors, including small molecule CGRP antagonists and large mononoclonal antibodies (mAbs), and the risk of gastrointestinal (GI) hypomotility, constipation or GI dysmotility with serious complications and intentional self-harm in individuals with evidence of a migraine diagnosis in the Sentinel Distributed Database. 

    We identified adults (≥18 years) with migraine who initiated a small molecule CGRP antagonist mAb, onabotulinum toxin, or triptan/dihydroergotamine between May 1, 2018, and June 30, 2025. Small molecule CGRP antagonist and mAb initiators were separately compared with each comparator for the risk of each outcome after 1:1 propensity score matching. 

    We distributed this request to six Sentinel Data Partners on February 9, 2026.

    The analytic packages 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
    CDER
    Time Period
    May 1, 2018 – June 30, 2025
    Analysis Type
    Retrospective Inferential
    Population / Cohort
    Individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database