Mp33-20 a Pharmacovigilance Study of Human Chorionic Gonadotropin-Associated Adverse Events in Males

You have accessJournal of UrologyHealth Services Research: Quality Improvement & Patient Safety II (MP33)1 May 2024MP33-20 A PHARMACOVIGILANCE STUDY OF HUMAN CHORIONIC GONADOTROPIN-ASSOCIATED ADVERSE EVENTS IN MALES Khalid Y. Alkhatib, John Ernandez, Ian Mitchell Harmatz, Peter Herzog, Quoc-Dien Trinh, and Martin Kathrins Khalid Y. AlkhatibKhalid Y. Alkhatib , John ErnandezJohn Ernandez , Ian Mitchell HarmatzIan Mitchell Harmatz , Peter HerzogPeter Herzog , Quoc-Dien TrinhQuoc-Dien Trinh , and Martin KathrinsMartin Kathrins View All Author Informationhttps://doi.org/10.1097/01.JU.0001009520.30626.80.20AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Human chorionic gonadotropin (hCG) is an exogenous analog of luteinizing hormone (LH). The only FDA-approved indication for males is to treat hypogonadotropic hypogonadism and cryptorchidism. hCG is used off-label to treat other conditions, including hypogonadism with various etiologies and infertility. Thus, little has been reported on the adverse side effects of hCG. We sought to explore the W.H.O pharmacovigilance database (VigiBase), the world's largest pharmacovigilance database, based on spontaneous individual case safety reports (ICSR), in order to report adverse events associated with the use of hCG. METHODS: We conducted a pharmacovigilance study using VigiBase on hCG use in men. We used reporting odds ratio (ROR), a surrogate measure of association used in disproportionality analysis, with 95% confidence intervals (CI), and descriptive demographic statistics were calculated. Conclusively for ease of interpretation, related indications and adverse events were grouped. Furthermore, we ran sensitivity analyses on indications, age, and gender to mitigate uncertainty in our results. RESULTS: A total of 530 adverse events of hCG usage in men were identified; only 308(58.11%) had indication reported. Age demographics were; 157(29.62%) children, 241(45.47%) adults, 132(29.91%) unknown age. There was a significant disproportionally signal with dosing and administration errors 75(14.15%) (ROR, 5.313; 95% CI, 4.162-6.784), reproduction and fertility disorders 13(2.45%) (ROR, 12.117; 95% CI, 6.987-21.012), testicular and epididymal disorders 13(2.45%) (ROR, 102.245; 95% CI, 58.919-177.430), and penile disorders 4(0.75%) (ROR, 41.819; 95% CI, 15.627-111.908). In our pediatric sub-group, edema, whether facial, peripheral, or generalized, represented 12.73% of adverse events, with a significant disproportionally signal (ROR, 10.052; 95% CI, 5.579-18.115). Main indications included; 85(16.03%) hypogonadism, 74(13.96%) cryptorchidism, 41(7.73%) anabolic steroids and substance abuse, 32(6.03%) hypothalamo-pituitary disorders, 30(5.66%) infertility, and testicular failure. CONCLUSIONS: We report the first global pharmacovigilance study of hCG usage and adverse events in males. hCG appears to be associated with a spectrum of perhaps underappreciated relevant physical side effects. Additionally, we noted a strong association of dosing and medication errors which raises concern about deficits in patient education and medication packaging for hCG, suggesting further investigational studies. Source of Funding: N/A © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e568 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Khalid Y. Alkhatib More articles by this author John Ernandez More articles by this author Ian Mitchell Harmatz More articles by this author Peter Herzog More articles by this author Quoc-Dien Trinh More articles by this author Martin Kathrins More articles by this author Expand All Advertisement PDF downloadLoading ...