Drug-induced urinary retention: a real-world pharmacovigilance study using FDA and Canada vigilance databases.

ABSTRACT:

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 P-values adjusted via Bonferroni correction, identified significant signals, which were then validated against drug labels and re-evaluated using the CVAR database. Ti

SUBMITTER: Dai X 

PROVIDER: S-EPMC11744018 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature