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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1466875
This article is part of the Research Topic Advances in Drug-induced Diseases Volume II View all 36 articles

Drug-Induced Urinary Retention: A Real-World Pharmacovigilance Study Using FDA and Canada Vigilance Databases

Provisionally accepted
Xianyu Dai Xianyu Dai Kai Yu Kai Yu Yu Chang Yu Chang Yuchuan Hou Yuchuan Hou *
  • First Hospital of Jilin University, Changchun, Hebei Province, China

The final, formatted version of the article will be published soon.

    Background: 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. Methods: 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 Pvalues 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. Results: 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. Conclusion: The study identifies a rising trend in drug-related UR reports over the past two 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.

    Keywords: Urinary Retention, adverse events, FAERS, CVaR, Pharmacovigilance

    Received: 18 Jul 2024; Accepted: 17 Dec 2024.

    Copyright: © 2024 Dai, Yu, Chang and Hou. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Yuchuan Hou, First Hospital of Jilin University, Changchun, Hebei Province, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.