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. 2024 Dec;11(4):691-700.
doi: 10.1007/s40801-024-00465-8. Epub 2024 Nov 13.

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

Shusuke Uekusa  1 , Keika Mogi  2 , Yuki Ota  2 , Yuki Hanai  2 , Kohei Kitagawa  3 , Takashi Yoshio  4   5 , Kazuhiro Matsuo  2
Affiliations

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

Shusuke Uekusa et al. Drugs Real World Outcomes. 2024 Dec.

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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Conflict of interest statement

Declarations. Statement of Ethics: This study analyzed a publicly available database; therefore, it did not require ethical approval. Conflict of Interest Statement: The authors have no conflicts of interest to declare. Funding Sources: There are no funding sources for this study. Author Contributions: K.K., T.Y., and K.M. conceived and designed the study; S.U., K.M., Y.H., and Y.O. analyzed the data; S.U. and K.M. wrote the manuscript. All authors read and approved the final version. Data Availability Statement: The data that support the findings of this study are not publicly available because the dataset is too large but are available from S.U. (shuusuke.uekusa@phar.toho-u.ac.jp) upon reasonable request.

Figures

Fig. 1
Fig. 1
UR reporting ratio according to patient demographics. RR, risk ratio
See this image and copyright information in PMC

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