Drug-induced urinary retention: a real-world pharmacovigilance study using FDA and Canada vigilance databases
BackgroundUrinary 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.MethodsThis study leveraged data from the FDA Adverse Event Reporti...
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2024.1466875/full |
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| author | Xianyu Dai Kai Yu Yu Chang Yuchuan Hou |
| author_facet | Xianyu Dai Kai Yu Yu Chang Yuchuan Hou |
| author_sort | Xianyu Dai |
| collection | DOAJ |
| description | BackgroundUrinary 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.MethodsThis 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 P-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.ResultsFrom 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.ConclusionThe 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. |
| format | Article |
| id | doaj-art-6ab0786801824fe5b89e162f5347c5de |
| institution | Kabale University |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj-art-6ab0786801824fe5b89e162f5347c5de2025-01-06T06:59:44ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-01-011510.3389/fphar.2024.14668751466875Drug-induced urinary retention: a real-world pharmacovigilance study using FDA and Canada vigilance databasesXianyu Dai0Kai Yu1Yu Chang2Yuchuan Hou3Department of Urology, The First Hospital of Jilin University, Changchun, ChinaDepartment of Urology, The First Hospital of Jilin University, Changchun, ChinaDepartment of Gastroenterology, The First Hospital of Jilin University, Changchun, ChinaDepartment of Urology, The First Hospital of Jilin University, Changchun, ChinaBackgroundUrinary 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.MethodsThis 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 P-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.ResultsFrom 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.ConclusionThe 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.https://www.frontiersin.org/articles/10.3389/fphar.2024.1466875/fullurinary retentionadverse eventsFAERSCanadian Vigilance Adverse Reaction (CVAR)pharmacovigilance |
| spellingShingle | Xianyu Dai Kai Yu Yu Chang Yuchuan Hou Drug-induced urinary retention: a real-world pharmacovigilance study using FDA and Canada vigilance databases Frontiers in Pharmacology urinary retention adverse events FAERS Canadian Vigilance Adverse Reaction (CVAR) pharmacovigilance |
| title | Drug-induced urinary retention: a real-world pharmacovigilance study using FDA and Canada vigilance databases |
| title_full | Drug-induced urinary retention: a real-world pharmacovigilance study using FDA and Canada vigilance databases |
| title_fullStr | Drug-induced urinary retention: a real-world pharmacovigilance study using FDA and Canada vigilance databases |
| title_full_unstemmed | Drug-induced urinary retention: a real-world pharmacovigilance study using FDA and Canada vigilance databases |
| title_short | Drug-induced urinary retention: a real-world pharmacovigilance study using FDA and Canada vigilance databases |
| title_sort | drug induced urinary retention a real world pharmacovigilance study using fda and canada vigilance databases |
| topic | urinary retention adverse events FAERS Canadian Vigilance Adverse Reaction (CVAR) pharmacovigilance |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2024.1466875/full |
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