madman
Super Moderator
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 under appreciated 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.
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 under appreciated 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.
