MP33-20 A PHARMACOVIGILANCE STUDY OF HUMAN CHORIONIC GONADOTROPIN-ASSOCIATED ADVERSE EVENTS IN MALES

• DOI: 10.1097/01.ju.0001009520.30626.80.20
• Publication Date: 2024-04-15T21:33:57Z
• Authors: Khalid Y. Alkhatib; John Ernandez; Ian Mitchell Harmatz; Peter Herzog; Quoc-Dien Trinh; Martin Kathrins
• Keywords: Human chorionic gonadotropin

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