Thaibah Hilal A, Banji Otilia J F, Banji David, Almansour Hadi A, Alshammari Thamir M
Department of Clinical Practice, College of Pharmacy, Jazan University, Jazan 45142, Saudi Arabia.
Pharmacy Practice Research Unit, College of Pharmacy, Jazan University, Jazan 45142, Saudi Arabia.
Pharmaceuticals (Basel). 2025 Jun 25;18(7):957. doi: 10.3390/ph18070957.
: Finasteride, a 5α-reductase inhibitor, is used for androgenetic alopecia and benign prostatic hyperplasia. However, concerns have emerged about its psychiatric side effects, including suicidality. This study analyzed finasteride-related reports from the FDA Adverse Event Reporting System (FAERS) to identify potential safety signals. : Adverse events reported from 2015 to 2024 were extracted using preferred terms, quantified using Bayesian analysis and disproportionality metrics, including empirical Bayesian geometric mean (EBGM), information component (IC), reporting odds ratio (ROR), and proportional reporting ratio (PRR). : Most were male (87%), with 43% aged 18-40 years, primarily using finasteride for hair loss. Disproportionality metrics for suicidality-related events fluctuated between 2019 and 2024. In 2019, the ROR was 27.51 (95% CI: 23.22-32.58), the PRR was 21.96 (95% CI: 18.54-26.01), the EBGM was 20.50, and the IC was 4.36. A slight decline was observed in 2020, a surge in 2021, and a peak in 2022 (ROR 34.64 (95% CI: 28.36-41.88), PRR 27.82 (95% CI: 22.30-34.61), EBGM 24.96, IC 4.64). Although a sharp rise in suicidality reports was noted in 2024, the rates of ROR and PRR dropped to 19.04 (95% CI: 17.02-21.30) and 16.53 (95% CI: 14.78-18.50), respectively. Serious outcomes such as disability (18.7%), life-threatening events (12.9%), and death (7.5%) were also noted. : The upward trend in suicidality-related safety signals among young male users since 2019, which peaked in 2024, reflects emerging safety concerns among finasteride users, reinforcing the need for pharmacovigilance. Collaborative action among healthcare professionals, regulatory authorities, and pharmaceutical companies, along with clear warnings and mental health assessments before and throughout finasteride therapy, can mitigate potential psychiatric risks and enhance patient safety.
非那雄胺是一种5α-还原酶抑制剂，用于治疗雄激素性脱发和良性前列腺增生。然而，人们对其精神方面的副作用，包括自杀倾向，产生了担忧。本研究分析了美国食品药品监督管理局不良事件报告系统（FAERS）中与非那雄胺相关的报告，以识别潜在的安全信号。
使用首选术语提取了2015年至2024年报告的不良事件，并使用贝叶斯分析和不成比例度量进行量化，包括经验贝叶斯几何均值（EBGM）、信息成分（IC）、报告比值比（ROR）和比例报告比（PRR）。
大多数为男性（87%），43%的年龄在18至40岁之间，主要使用非那雄胺治疗脱发。与自杀倾向相关事件的不成比例度量在2019年至2024年期间波动。2019年，ROR为27.51（95%置信区间：23.22 - 32.58），PRR为21.96（95%置信区间：18.54 - 26.01），EBGM为20.50，IC为4.36。2020年略有下降，2021年激增，2022年达到峰值（ROR 34.64（95%置信区间：28.36 - 41.88），PRR 27.82（95%置信区间：22.30 - 34.61），EBGM 24.96，IC 4.64）。尽管2024年自杀倾向报告急剧增加，但ROR和PRR分别降至19.04（95%置信区间：17.02 - 21.30）和16.53（95%置信区间：14.78 - 18.50）。还注意到了严重后果，如残疾（18.7%）、危及生命的事件（12.9%）和死亡（7.5%）。
自2019年以来，年轻男性使用者中与自杀倾向相关的安全信号呈上升趋势，并在2024年达到峰值，这反映了非那雄胺使用者中出现的安全担忧，强化了药物警戒的必要性。医疗保健专业人员、监管机构和制药公司之间的合作行动，以及在非那雄胺治疗前和治疗期间进行明确的警告和心理健康评估，可以减轻潜在的精神风险并提高患者安全性。
