Analytical Review of Depression and Suicidality from Finasteride

Summary

This paper is dedicated to the memory of a healthy person who started taking finasteride several years ago, “just” to improve his hair. Within a week, he developed severe neuropsychiatric symptoms that did not abate after stopping the drug. Treatment attempts by the best specialists did not help, and a few months later, he died by suicide. Finasteride, a 5α-reductase inhibitor of testosterone conversion, was approved by the US Food and Drug Administration (FDA) in 1997 for treating androgenetic alopecia (AGA). The FDA recognized mental adverse reactions starting with depression in 2011 and then suicidality in 2022. The European Medicines Agency (EMA) acknowledged that finasteride can cause suicide in 2025. This might have been too late for some users of the medication. Could the neuropsychiatric risks from finasteride have been detected earlier? In this paper, we will first review current evidence indicating increased risk for depression and/or suicidal behavior with the use of finasteride. We will then estimate the harms potentially caused by the delayed recognition of the neuropsychiatric risk associated with finasteride use. We will analyze the historical development and the causes for this delayed risk recognition. Finally, we will suggest policy recommendations for regulating and monitoring drug safety. Current Evidence Indicating a Risk of Depression and Suicidality From Finasteride Use Proactive pharmacovigilance with analysis of databases uses two approaches. The first, disproportionality analysis, examines the number of adverse events reported to a database for finasteride in comparison to similar reports for other medications. The second approach uses data mining in large sets of patients’ records, comparing health outcomes for those treated with finasteride to controls with similar background confounders. Table 1 summarizes the studies in the last decade examining a potential link between neuropsychiatric reactions and finasteride exposure. When prescribe...