Isolated depressive disorders and suicidality with finasteride use for androgenetic alopecia: A call for enhanced vigilance.

Objective: To describe the clinical characteristics of depressive disorders and suicidality not associated with sexual dysfunction among users of finasteride 1mg/day for androgenetic alopecia.

Methods: A retrospective descriptive analysis was conducted using data from the French National Pharmacovigilance Database (BNPV) from 1985 to May 2024. Cases were selected based on the presence of depressive or suicidal symptoms, classified in Medical Dictionary for Regulatory Activities (MedDRA) high-level group terms, with no co-reported sexual dysfunction.

Results: Forty cases of depression or suicidality were identified in men treated with finasteride, with a median age of 31years. Most cases (62.5%) were classified as serious. In half of the cases, symptoms occurred within 9months of treatment initiation. Suicidality (ideation or attempts) was present in 40% of cases. Among patients who discontinued treatment, 45.2% reported symptom improvement. In unresolved cases (n=10), the median persistence of symptoms after withdrawal was 20.2months. A positive rechallenge was observed in two patients. Only 22.5% had a personal or family psychiatric history, and 17.5% reported a significant impact on quality of life.

Conclusion: While adverse psychiatric drug reactions, including depressive symptoms and suicidality, are often reported in conjunction with sexual dysfunction, this study highlights the severity of depressive effects associated with finasteride, particularly the risk of suicidality even in the absence of associated sexual dysfunction or psychiatric history. The persistence of depressive symptoms sometimes beyond 20months post-discontinuation, underscores the need for adapted management and long-term monitoring. Finally, these findings highlight the need for thorough psychiatric evaluation at the time of prescription and ongoing suicide risk assessment throughout the course of treatment.