Dai Xianyu, Yu Kai, Chang Yu, Hou Yuchuan
Department of Urology, The First Hospital of Jilin University, Changchun, China.
Department of Gastroenterology, The First Hospital of Jilin University, Changchun, China.
Front Pharmacol. 2025 Jan 6;15:1466875. doi: 10.3389/fphar.2024.1466875. eCollection 2024.
Urinary retention (UR) is a clinical condition where patients cannot fully empty their bladder. Although numerous drugs are associated with UR, comprehensive and reliable studies identifying drugs that induce UR are scarce.
This study leveraged data from the FDA Adverse Event Reporting System (FAERS) and the Canadian Vigilance Adverse Reaction (CVAR) database to explore adverse events (AEs) related to UR from 2004 to Q1 2024. The top 50 drugs were analyzed for annual reporting trends using linear regression. Disproportionality analysis using the reporting odds ratio (ROR) method, with -values adjusted via Bonferroni correction, identified significant signals, which were then validated against drug labels and re-evaluated using the CVAR database. Time-to-onset analysis was also performed.
From 2004 to Q1 2024, FAERS recorded 17,785,793 AEs, with 16,183 (0.09%) identified as UR cases. The median age among these cases was 65 years, with males comprising 53.4%. There were significant annual increases in UR reports associated with antineoplastic agents (0.19% per year) and antidiabetic drugs (0.09% per year), while reports linked to bronchodilators decreased (-0.53% per year). Disproportionality analysis revealed significant signals for 34 drugs (68%), with the highest RORs observed in Fesoterodine, Mirabegron, and Solifenacin. Initial signal detection identified potential new UR signals for Abiraterone, Valacyclovir, Fluoxetine, Empagliflozin, Clopidogrel, and Amlodipine, with CVAR confirming signals for Abiraterone, Fluoxetine, and Empagliflozin. The median time to onset of UR was 29 days, with over half of the cases occurring within 30 days of initiating medication.
The study identifies a rising trend in drug-related UR reports over the past 2 decades. The validation of new signals for Abiraterone, Fluoxetine, and Empagliflozin underscores the critical need for continuous drug safety monitoring and targeted research to better understand the mechanisms behind drug-induced UR.
尿潴留（UR）是一种临床病症，患者无法完全排空膀胱。尽管有多种药物与尿潴留相关，但确定诱发尿潴留药物的全面且可靠的研究却很匮乏。
本研究利用美国食品药品监督管理局不良事件报告系统（FAERS）和加拿大警戒不良反应（CVAR）数据库的数据，探究2004年至2024年第一季度与尿潴留相关的不良事件（AE）。使用线性回归分析了排名前50的药物的年度报告趋势。采用报告比值比（ROR）方法进行不成比例分析，并通过Bonferroni校正调整P值，以识别显著信号，然后对照药物标签进行验证，并使用CVAR数据库重新评估。还进行了发病时间分析。
2004年至2024年第一季度，FAERS记录了17,785,793例不良事件，其中16,183例（0.09%）被确定为尿潴留病例。这些病例的中位年龄为65岁，男性占53.4%。与抗肿瘤药（每年0.19%）和抗糖尿病药（每年0.09%）相关的尿潴留报告有显著年度增加，而与支气管扩张剂相关的报告则减少（每年-0.53%）。不成比例分析显示34种药物（68%）有显著信号，在非索罗定、米拉贝隆和索利那新中观察到最高的报告比值比。初始信号检测确定阿比特龙、伐昔洛韦、氟西汀、恩格列净、氯吡格雷和氨氯地平为潜在的新尿潴留信号，CVAR证实了阿比特龙、氟西汀和恩格列净的信号。尿潴留的中位发病时间为29天，超过一半的病例在开始用药后30天内发生。
该研究确定了过去20年与药物相关的尿潴留报告呈上升趋势。对阿比特龙、氟西汀和恩格列净新信号的验证强调了持续进行药物安全性监测和针对性研究的迫切需求，以便更好地了解药物诱发尿潴留背后的机制。
