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Open Access 13-11-2024 | Benign Prostatic Hypertrophy | Original Research Article

A Pharmacovigilance Study on Psychotropic Agent-Induced Urinary Retention Using the Japanese Adverse Drug Event Report Database

Authors: Shusuke Uekusa, Keika Mogi, Yuki Ota, Yuki Hanai, Kohei Kitagawa, Takashi Yoshio, Kazuhiro Matsuo

Published in: Drugs - Real World Outcomes | Issue 4/2024

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Abstract

Introduction

Psychotropic drugs have been reported to cause urinary retention (UR) via anticholinergic and other mechanisms. However, UR has not received much attention because of its non-fatal symptoms. We investigated the occurrence of UR associated with psychotropic drugs using the Japanese Adverse Drug Event Report (JADER) database.

Methods

Using the JADER database, we calculated reporting odds ratios for UR for 74 psychotropic drugs. Multivariate logistic regression analysis was used to adjust for the effects of sex, underlying disease, and age on UR. Variable selection included forced entry for sex, age, benign prostatic hyperplasia (BPH), depression, and backward-forward stepwise selection for each drug.

Results

A total of 887,704 cases were reported, of which 4653 (0.52%) had UR. In terms of sex, 0.79% (3401/429,372 cases) and 0.43% (1797/415,358 cases) of male and female patients had UR. In terms of age, 0.31% (892/288,676 cases) and 0.68% (3463/506,907 cases) of patients aged < 60 years and 60 years or older had UR. Among the underlying diseases, 8.22% (930/11,316 cases) and 0.43% (3723/876,388 cases) of patients with BPH and without BPH had UR, respectively. Further, 1.99% (337/16,959 cases) and 0.50% (4316/870,745 cases) of patients with depression and without depression had UR, respectively. Overall, 38 psychotropic drugs met the criteria for signal detection. In logistic regression, a total of 783,083 patients of discernible age and sex were included. The selected variables were sex, age, BPH, depression, and 23 drugs, including quetiapine [adjusted reporting odds ratio (ROR) 95% confidence interval (CI): 1.46–2.81], chlorpromazine (adjusted ROR 95%CI: 1.29–3.13), etizolam (adjusted ROR 95%CI: 1.47–3.09), maprotiline (adjusted ROR 95%CI: 1.99–8.34), mirtazapine (adjusted ROR 95%CI: 1.37–2.88), and duloxetine (adjusted ROR 95%CI: 2.15–4.21).

Conclusions

Many psychotropic drugs induce UR, which may be owing to their pharmacological effects. Appropriate monitoring is needed, especially in patients with other risk factors for UR.
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Metadata
Title
A Pharmacovigilance Study on Psychotropic Agent-Induced Urinary Retention Using the Japanese Adverse Drug Event Report Database
Authors
Shusuke Uekusa
Keika Mogi
Yuki Ota
Yuki Hanai
Kohei Kitagawa
Takashi Yoshio
Kazuhiro Matsuo
Publication date
13-11-2024
Publisher
Springer International Publishing
Published in
Drugs - Real World Outcomes / Issue 4/2024
Print ISSN: 2199-1154
Electronic ISSN: 2198-9788
DOI
https://doi.org/10.1007/s40801-024-00465-8