Finasteride-Associated Suicide and Depression in Men Treated for Hypogonadism and Impotence

Abstract

ABSTRACT Introduction Recent studies have investigated the use of finasteride in the management of alopecia and benign prostatic hyperplasia (BPH). Finding suggest significant increased reporting odds ratios (ROR) of suicidality and psychological adverse events in patients younger than 45. As alopecia and BPH are side effects of testosterone therapy, we sought to evaluate the ratio of adverse events in patients who were medically treated for hypogonadism and sexual dysfunction. Objective The purpose of this study is to evaluate the ratio of adverse events in patients on finasteride who were also medically treated for hypogonadism and sexual dysfunction. Methods We surveyed VigiBase, the World Health Organization's global database of individual case safety reports to detect adverse reactions of interest reported with finasteride. These findings were stratified by patients also treated with testosterone, phosphodiesterase 5 inhibitors (PDE5i), and a combination of the two. Reported adverse events were reported as anxiety disorder and symptoms, depressed mood disorders and disturbance, and suicidal and self injurious behaviors. The strength of association between these events and medications were demonstrated by ROR. Patients stratified by indication (BPH and alopecia) and age (<45 and >45 years). Case data were obtained in June of 2021 and analyzed from reporting year, age, sex, and indication. Results The VigiBase contained 611 reports of suicidality, 2352 reports of anxiety disorders and symptoms, and 2392 reports of depressed mood disorders and disturbances in finasteride users 3994 male [96.9%]; 844 of 3426 [24.6%] with data available aged 18-44 years. A significant disproportionality signal towards suicidality was increased in finasteride alone (ROR, 1.89; 95% CI, 1.74-2.04). This signal was decreased when evaluated for the combination of finasteride and PDE5i (ROR, 0.22; 95% CI 0.12-0.39) and finasteride and testosterone (ROR 0.80; 95% CI 0.35-1.78). Combination finasteride with PDE5i demonstrated a decreased ROR in anxiety disorders (ROR 0.21; 95% CI 0.16-0.27) and in depressed mood disorders (ROR 0.25; 95% CI 0.19-0.33). Combination finasteride with testosterone also demonstrated a decreased ROR in anxiety disorders (ROR 1.25; 95% CI 0.89-1.76) and in depressed mood disorders (ROR 1.23; 95% CI 0.88-1.72). Conclusions RORs of suicidality and psychological adverse events were not elevated in patients with concomitant use of finasteride with testosterone. Moreover, RORs were decreased in patients with use of finasteride and PDE5i. This analysis suggests that treatment of a patient's underlying hypogonadism or sexual dysfunction may be protective in the use of finasteride for alopecia or BPH. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Abbie, American Medical Systems, Augmenta LLC, Clarus Therapeutics, Endo Pharmaceuticals, Lipocine, Vault Health