Investigation of Suicidality and Psychological Adverse Events in Patients Treated With Finasteride

Abstract

ImportanceThere is ongoing controversy about the adverse events of finasteride, a drug used in the management of alopecia and benign prostatic hyperplasia (BPH). In 2012, reports started emerging on men who had used finasteride and either attempted or completed suicide.ObjectiveTo investigate the association of suicidality (ideation, attempt, and completed suicide) and psychological adverse events (depression and anxiety) with finasteride use.Design, Setting, and ParticipantsThis pharmacovigilance case-noncase study used disproportionality analysis (case-noncase design) to detect signals of adverse reaction of interest reported with finasteride in VigiBase, the World Health Organization’s global database of individual case safety reports. To explore the strength of association, the reporting odds ratio (ROR), a surrogate measure of association used in disproportionality analysis, was used. Extensive sensitivity analyses included stratifying by indication (BPH and alopecia) and age (≤45 and >45 years); comparing finasteride signals with those of drugs with different mechanisms but used for similar indications (minoxidil for alopecia and tamsulosin hydrochloride for BPH); comparing finasteride with a drug with a similar mechanism of action and adverse event profile (dutasteride); and comparing reports of suicidality before and after 2012. Data were obtained in June 2019 and analyzed from January 25 to February 28, 2020.ExposuresReported finasteride use.Main Outcomes and MeasuresSuicidality and psychological adverse events.ResultsVigiBase contained 356 reports of suicidality and 2926 reports of psychological adverse events (total of 3282 adverse events of interest) in finasteride users (3206 male [98.9%]; 615 of 868 [70.9%] with data available aged 18-44 years). A significant disproportionality signal for suicidality (ROR, 1.63; 95% CI, 1.47-1.81) and psychological adverse events (ROR, 4.33; 95% CI, 4.17-4.49) in finasteride was identified. In sensitivity analyses, younger patients (ROR, 3.47; 95% CI, 2.90-4.15) and those with alopecia (ROR, 2.06; 95% CI, 1.81-2.34) had significant disproportionality signals for increased suicidality; such signals were not detected in older patients with BPH. Sensitivity analyses also showed that the reports of these adverse events significantly increased after 2012 (ROR, 2.13; 95% CI, 1.91-2.39).Conclusions and RelevanceIn this pharmacovigilance case-noncase study, significant RORs of suicidality and psychological adverse events were associated with finasteride use in patients younger than 45 years who used finasteride for alopecia. The sensitivity analyses suggest that these disproportional signals of adverse events may be due to stimulated reporting and/or younger patients being more vulnerable to finasteride’s adverse effects.

From organ injury to disability: a proposed model for 5-alpha reductase inhibitor syndrome

“…These included: Penile Size Reduced, Peyronie's Disease, Male Genital Atrophy and Penile Curvature. While psychogenic explanations have frequently been proposed to explain these AEs in connection with 5ARI treatment, [1][2][3][4][5][6][7][8] in fact the terms are non-specific as to origin. It would therefore be inappropriate prima facie to rule out a drug-related cause (doing so recalls the diagnostic biases of premature closure and confirmation bias 35 ).…”

“…In the last decade, there has emerged a cottage industry of doctors and researchers advancing psychosocial explanations of persistent dysfunctions after discontinuation of 5alpha reductase inhibitors (PD-5ARI). [1][2][3][4][5][6][7][8] Articles and conference presentations hint at paranormal phenomena with titles such as: "Post-Finasteride Syndrome: Real or Imagined?" 9 Three recent papers from leading lights in urology-strikingly similar in their design, findings and conclusions-have sown doubts about the validity of adverse event (AE) reports.…”

“…9 Three recent papers from leading lights in urology-strikingly similar in their design, findings and conclusions-have sown doubts about the validity of adverse event (AE) reports. 1,3,4 Doctors and researchers have ventured the following explanations for reports of PD-5ARI: ordinary depression, nocebo effect, psychogenic erectile dysfunction, mass psychogenic illness, distress and psychopathology associated with hair loss, dissatisfaction, advocacy group efforts, stimulated reporting and litigation interests.…”

Non-thermal atmospheric pressure plasma activates Wnt/β-catenin signaling in dermal papilla cells

“…Hair loss can cause significant psychosocial distress for affected patients, and therapeutic options are limited. Practical use of FDA-approved medications for androgenetic alopecia, such as minoxidil and finasteride, has been restricted due to adverse drug events 1 , 2 . Thus, there is an urgent need for novel, non-pharmacological therapeutics to treat hair loss.…”

Efficacy and Safety of Deep Acupuncture at Qugu Point (CV2) for Benign Prostatic Hyperplasia: Study Protocol for a Randomized Controlled Trial

“…Surgical is often suggested for men with poor e cacy of medications and with severe complications (e.g., renal insu ciency, refractory urinary retention, recurrent urinary tract infections) [12] . However, some patients still troubled by poor curative effect or side-effects of medications [13,14] or surgical treatments [15]. These patients are interested in explore more alternative and complementary approaches.…”