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Original Investigation
November 11, 2020

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

Author Affiliations
  • 1Division of Urological Surgery and Center for Surgery and Public Health, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 2Faculty of Medicine, McGill University, Montreal, Québec, Canada
  • 3Research Program in Men’s Health: Aging and Metabolism, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 4Division of Urology, Centre Hospitalier de l’Université de Montréal, Université de Montréal, Montreal, Québec, Canada
JAMA Dermatol. 2021;157(1):35-42. doi:10.1001/jamadermatol.2020.3385
Key Points

Question  Is finasteride use associated with more spontaneous reports of suicidality, depression, and/or anxiety?

Findings  This pharmacovigilance case-noncase study of 3282 users of finasteride used VigiBase, the World Health Organization’s global database of individual case safety reports, and found a disproportional signal of suicidality, depression, and anxiety associated with finasteride use for alopecia in patients younger than 45 years. No such signal was associated with drugs that had different mechanisms of action but similar indications or with drugs that had similar mechanisms and adverse effect profiles.

Meaning  This study’s findings suggest that the risk of suicidality, depression, and anxiety should be considered when prescribing finasteride to younger patients with alopecia who may be more vulnerable to the drug’s adverse effects; this association may be biased by stimulated reporting and should be further investigated.

Abstract

Importance  There 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.

Objective  To investigate the association of suicidality (ideation, attempt, and completed suicide) and psychological adverse events (depression and anxiety) with finasteride use.

Design, Setting, and Participants  This 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.

Exposures  Reported finasteride use.

Main Outcomes and Measures  Suicidality and psychological adverse events.

Results  VigiBase 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 Relevance  In 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.

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