Finasteride and Suicide: A Postmarketing Case Series

Abstract

Background: In 2011, depression was added to the product labeling of finasteride in the USA. The US Food and Drug Administration's Adverse Event Reporting System database contains at least 36 death cases for finasteride. The aim of this study is to characterize the clinical histories and symptoms reported by a series of 6 suicide victims who took finasteride for treatment of androgenic alopecia. Methods: Medical records and autopsy reports were provided by family members of the cases. Relevant information was extracted according to guidelines for submitting adverse event reports. Results: An important pattern of symptoms was common among all cases who committed suicide in the setting of finasteride use-insomnia and persistent sexual dysfunction after medication discontinuation. Insomnia and fatigue/ tiredness were some of the most debilitating symptoms. Apart from 1 case who had hyperlipidemia, there was no documentation of concomitant medication use with finasteride or any baseline medical or psychiatric diagnoses prior to starting finasteride. The findings of this postmarketing series may not be generalizable to the population of men who committed suicide in the setting of finasteride use due to small sample size and bias. Associations between medication use and symptoms cannot prove causality. Conclusion: Men under the age of 40 who use finasteride for alopecia are at risk for suicide if they develop persistent sexual adverse effects and insomnia. Further research is needed to establish whether finasteride has a causal relationship to suicide.

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

“…For example, the disproportional signals of adverse events in association with finasteride use could result from adverse effects, such as persistent sexual dysfunction, having a greater toll on younger patients using finasteride to treat a nonurologic condition . This hypothesis is supported by a small postmarketing case series of 6 suicide completers who took finasteride for the treatment of androgenic alopecia . Among all 6 cases, investigators found evidence of persistent sexual dysfunction after discontinuation of finasteride treatment.…”

Suicidal risk associated with finasteride versus dutasteride among men treated for benign prostatic hyperplasia: nationwide cohort study

“…Biological studies have shown that finasteride crosses the blood–brain barrier and can be involved in mood changes by affecting the concentration of neuro-steroids and their metabolites in the cerebrospinal fluid 15 – 18 . Psychiatric and suicidal events can appear early after treatment initiation 13 , 14 and persist long after treatment discontinuation, as described in the “post-finasteride syndrome”, consisting of an association of sexual, physical, and psychological symptoms that develop during or after finasteride exposure and persist after discontinuation 7 , 19 . Regarding psychological symptoms, clinically significant depression was reported in 50% of a sample of men with post-finasteride syndrome, and anxiety in 34% 20 .…”

Dual‐Mode Vasodilator M119 Delivery to Hair Follicle via Dissolving Microneedle for Advanced Alopecia Treatment

“…[ 3 ] Furthermore, a recent study revealed that finasteride can cause adverse effect on mental health and increases the risk of suicidality and depression. [ 4,5 ]…”

“…[3] Furthermore, a recent study revealed that finasteride can cause adverse effect on mental health and increases the risk of suicidality and depression. [4,5] To overcome these side effects caused by oral administration of finasteride, minoxidil, a topical alopecia drug, has been developed and widely used in clinics. However, minoxidil topical formulations experience difficulty in delivering the drug to the deep hypodermic region (>700 μm), where hair follicles are located, against the skin barrier.…”