{"title":"Isolated depressive disorders and suicidality with finasteride use for androgenetic alopecia: A call for enhanced vigilance.","authors":"Hélène Géniaux, Marie-Laure Laroche","doi":"10.1016/j.therap.2025.09.004","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To describe the clinical characteristics of depressive disorders and suicidality not associated with sexual dysfunction among users of finasteride 1mg/day for androgenetic alopecia.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":1.8000,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapie","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.therap.2025.09.004","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
Thérapie is a peer-reviewed journal devoted to Clinical Pharmacology, Therapeutics, Pharmacokinetics, Pharmacovigilance, Addictovigilance, Social Pharmacology, Pharmacoepidemiology, Pharmacoeconomics and Evidence-Based-Medicine. Thérapie publishes in French or in English original articles, general reviews, letters to the editor reporting original findings, correspondence relating to articles or letters published in the Journal, short articles, editorials on up-to-date topics, Pharmacovigilance or Addictovigilance reports that follow the French "guidelines" concerning good practice in pharmacovigilance publications. The journal also publishes thematic issues on topical subject.
The journal is indexed in the main international data bases and notably in: Biosis Previews/Biological Abstracts, Embase/Excerpta Medica, Medline/Index Medicus, Science Citation Index.
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