Acting Deputy Director, Office of Pharmacovigilance and Epidemiology U.S. Food and Drug Administration Silver Spring, United States
Background: Utilization of gonadotropin-releasing hormone (GnRH) agonist products among adolescents is not well characterized in the current literature.
Objectives: To assess GnRH agonist product use in adolescents and to examine possible diagnoses associated with their use.
Methods: Using three data sources (Symphony Health's Integrated Dataverse®, aggregated health care data; Merative™ MarketScan®, an administrative claims database; and Syneos Health’s TreatmentAnswers™, a healthcare practitioner survey database) we assessed GnRH agonist use in adolescents 12-16 years old. To determine potential reasons for use, we evaluated the occurrence or mention of diagnoses of interest occurring in close temporal proximity to GNRH agonist use in two data sources (MarketScan and TreatmentAnswers).
Results: In Integrated Dataverse, we identified 113,792,651 adolescents with prescription activity between 2010 and 2021, of whom 17,286 (0.02%) had GnRH agonist use. Use increased modestly during this period, from 1,407 adolescents in 2010 to 2,462 in 2021. GnRH agonists were most used in adolescents 12 years old (587 individuals in 2021), compared to other ages. In MarketScan, we identified 5,174,410 eligible members between October 1, 2015 and June 30, 2021, of whom 1,028 (0.02%) received a GnRH agonist. Of these GnRH agonist users, over half (580 adolescents, 56.4%) had a claim with a diagnosis of gender dysphoria. The median time between adolescents' first and last GnRH agonist claims was 160 days (IQR 28-365 days, mean 251 days [SD 289 days]). In TreatmentAnswers, we identified an estimated 50,000 health care practitioner office visits between 2010 and 2021 where GnRH agonist use was discussed with adolescents. Diagnoses most commonly associated with GnRH agonist use in these patients were disorders of puberty (35% of office visits) and congenital malformations of the uterus and cervix (24% of office visits). This data source reported no GnRH agonist use associated with gender dysphoria in adolescents.
Conclusions: GnRH agonist use does not appear to be common among adolescent patients. Possible diagnoses associated with GnRH agonist use included puberty disorders and gender dysphoria.
