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Gonadotropin-Releasing Hormone (GnRH) Agonists & Utilization Characterization

    Basic Details
    Last Updated
    Thursday, May 25, 2023
    Original Posting Date
    Health Outcome(s)
    utilization characterization
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    FDA conducted an analysis to assess the feasibility of studying the long-term safety of gonadotropin-releasing hormone (GnRH) agonist use in adolescents through Sentinel. The primary objective was to characterize GnRH agonist use in adolescents and to examine possible diagnoses associated with their use. Sentinel findings demonstrated that a small cohort of adolescents with GnRH agonist use was identified. Most of this use appeared to be short term: half of patients had less than 5 months of GnRH agonist therapy and three-quarters of patients had less than 11 months of therapy. Diagnosis codes occurring in proximity to a claim for a GnRH agonist included those related to puberty disorders and gender dysphoria. Sentinel findings suggest that safety studies of GnRH agonist use among adolescents may be feasible, depending on the outcome of interest.