Signal Detection Between 5-Alpha Reductase Inhibitors and the Risk of Suicidality and Depression: An International Pharmacovigilance Analysis

This study analyzed over 35 million adverse event reports to explore the link between 5-alpha reductase inhibitors, specifically finasteride and dutasteride, and the risk of suicidality and depression. It found significant signals associating finasteride with increased risks of suicidality (ROR, 7.28) and depression (ROR, 28.18), particularly in younger individuals aged 18–44. Dutasteride did not show a significant signal for suicidality and had a weaker signal for depression. The adverse effects were typically reported after 3 months of drug use. While causality is not confirmed, the study highlights the need for further research to validate these associations and investigate the mechanisms involved.