Abstract
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.
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.
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.
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.
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.
Failing Public Health Again? Analytical Review of Depression and Suicidality From Finasteride — summary, novelty, and critique
Summary (what the paper argues)
- Claim: Current evidence indicates finasteride can cause depression and suicidality, sometimes persisting after discontinuation.
- Evidence base: The author synthesizes 8 post-marketing database/records studies (2017–2024): four disproportionality analyses (FAERS, VigiBase) and four healthcare-records studies—all reporting increased signals/risks for depression, anxiety, suicidal ideation/behaviour (especially when prescribed for androgenetic alopecia).
- Biological plausibility: 5-α-reductase inhibition lowers neurosteroids (notably allopregnanolone) that modulate mood; animal/human data are cited as mechanistic support.
- Public-health impact estimate: Extrapolating from background rates and global exposure (~4.6 million patients over ~10–20 years), the paper suggests hundreds of thousands may have experienced depression and hundreds to thousands may have died by suicide; reported FAERS suicides are far below expected, implying under-reporting.
- Regulatory history & critique: FDA added depression to labeling in 2011 and suicidality in 2022; EMA formally recognized suicidal thoughts as a side effect in 2025. The paper argues regulators and the manufacturer failed to do timely, simple analytical pharmacovigilance.
- Policy recommendations: Suspend marketing for alopecia unless new evidence demonstrates safety (or a non-CNS-penetrant alternative exists); mandate/enforce ongoing post-approval analytical studies; systematically record medication histories in suicide investigations.
Context note: Separately, Reuters reported the EMA’s 2025 decision to list suicidal thoughts for 1 mg finasteride after an EU safety review. (Reuters)
What’s novel here
- First focused, analytic post-marketing review tying together both disproportionality analyses and healthcare-records data specifically for neuropsychiatric outcomes of finasteride, with an explicit causal interpretation.
- Quantified “missed-harm” framing: A simple expected-vs-reported table contrasts background suicide/ideation counts with FAERS reports to argue serious under-ascertainment.
- Regulatory process analysis: Beyond summarizing risks, the article reconstructs timelines and argues for enforceable commitments to analytical pharmacovigilance as a condition of approval.
Critique (strengths & limitations)
Strengths
- Convergent signals across methods: Multiple independent datasets (FAERS, VigiBase, national EHRs) point the same way for AGA users, improving credibility despite each method’s weaknesses.
- Plausible mechanism: Neurosteroid depletion is a coherent biological pathway linking finasteride to mood disorders.
- Clear public-health framing and actionable policy asks.
Limitations / points to challenge
- Observational evidence only: Disproportionality analyses detect signals, not incidence; they are vulnerable to notoriety/reporting bias (media attention, litigation, advocacy). The review acknowledges but does not fully quantify this.
- Confounding/comorbidity detail is limited: Healthcare-records studies may have incomplete data on psychiatric history, concomitant drugs, and hair-loss–related distress; residual confounding can inflate associations.
- Generalization across indications: Effects appear most consistent in younger AGA users; data are mixed in older BPH populations where symptom relief itself can improve mood—this heterogeneity tempers blanket causal claims.
- Back-of-envelope harm estimates: The expected-vs-reported suicide counts assume exposure sizes, adherence, and base rates that are uncertain; the author labels them speculative. A sensitivity analysis would strengthen credibility.
- Causality language: The paper states evidence “shows [finasteride] can cause” depression/suicidality; some contemporary dermatology/epidemiology reviews remain more cautious (association ≠proof), so readers should weigh this assertiveness against ongoing debate. (PubMed)
Practical takeaways
- For cosmetic AGA use, discuss mood-risk explicitly, screen for prior mood disorders, and ensure early follow-up; consider alternatives if symptoms emerge.
- Clinicians and coroners should systematically record medication histories (including recently discontinued finasteride) in suicide/attempt investigations.
- Regulators should require routine analytical pharmacovigilance and transparent publication for widely used drugs with plausible CNS effects.
If you want, I can tabulate the eight studies the paper lists (database, years, effect sizes) and add links to the originals.