Investigation of Suicidality and Psychological Adverse Event
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Is finasteride use associated with more spontaneous reports of suicidality, depression, and/or anxiety?

There is ongoing controversy about the adverse events of finasteride, a drug used in the management of alopecia and benign prostatic hyperplasia (BPH). Reports started emerging on men who had used finasteride and either attempted or completed suicide. To investigate the association of suicidality (ideation, attempt, and completed suicide) and psychological adverse events (depression and anxiety) with finasteride use, a study was conducted.

This pharmacovigilance case-noncase study used disproportionality analysis (case-noncase design) to detect signals of adverse reaction of interest reported with finasteride in VigiBase. 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 (less than 45 and more than 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.

VigiBase contained 356 reports of suicidality and 2926 reports of psychological adverse events in finasteride users (3206 male; 615 of 868 with data available aged 18-44 years). A significant disproportionality signal for suicidality (ROR, 1.63) and psychological adverse events (ROR, 4.33) in finasteride was identified. In sensitivity analysis, younger patients (ROR, 3.47) and those with alopecia (ROR, 2.06) had significant disproportionality signals for increased suicidality; such signals were not detected in older patients with BPH. Sensitivity analysis also showed that the reports of these adverse events significantly increased after 2012 (ROR, 2.132).

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 analysis 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.