Conclusions and Relevance: Current evidence shows that finasteride use can cause depression and suicidality. A historical literature review discloses gaps between research evidence and regulatory steps. The lesson is that before approving a medication for the market, regulators should require manufacturers to commit to performing and disclosing ongoing postapproval analytical studies, and this requirement needs to be enforced.
Causes for Delayed Risk Recognition: The long delay in recognizing the risks associated with finasteride exposure includes the manufacturer’s failure to perform and publish simple pharmacovigilance studies using database analyses and regulators’ failure to request such studies from the manufacturer or to perform them.
Potential Harms and Implications: Over 20 years worldwide, hundreds of thousands may have endured depression, and hundreds may have died by suicide. According to the precautionary principle, such a risk from a cosmetic medication suggests a benefit-to-harm balance that justifies action to protect the public, and the burden of proving that the intervention is not harmful falls on manufacturers.
Observations: Concerns about depression from finasteride were raised in several studies as early as 2002. Between the years 2017 and 2023, 4 independent analyses of adverse event reporting systems and 4 studies using data mining of healthcare records indicated a significant increase in the risk for depression, anxiety, and/or suicidal behavior with the use of finasteride. There has been, therefore, a two-decade delay in the realization of the incidences and the gravity of neuropsychiatric effects, allowing harm from a medicine prescribed for a cosmetic indication of hair loss.
Background: Finasteride, widely prescribed for androgenetic alopecia, has long been suspected of causing severe neuropsychiatric reactions, including depression, anxiety, and suicidality, even after the drug is discontinued. This study systematically reviews evidence that supports this suspicion and analyzes the reasons for this delayed recognition.
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 prescribed mainly for AGA, all reports suggest that finasteride can cause depression, anxiety, suicide ideation, and suicides. Assuming a null hypothesis (finasteride does not affect mood) and a 50% chance of 1 result against this hypothesis, the probability of getting all 8 studies concluding against the null hypothesis by chance is 0.58 = 0.0039.
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