| アブストラクト | Background/Objectives: The combination drug sulfamethoxazole/trimethoprim (ST) is a broad-spectrum antibiotic used against various infections; however, it is associated with several serious adverse events. The ST package inserts contain warnings about these adverse events. However, warnings vary internationally, and specific measures to address ST-related adverse events are unclear. Therefore, we aimed to comprehensively evaluate ST-related adverse events using the Japanese Adverse Drug Event Report (JADER) database and analyze the onset time for each event. Methods: Adverse events due to ST were analyzed using the JADER database between April 2004 and June 2023. The reported odds ratio and 95% confidence interval (95% confidence interval [CI]) were calculated, with a signal detected if the 95% CI lower limit exceeded 1. The Weibull distribution was used to characterize the onset time of adverse events with detected signals. Results: The total number of cases in the JADER database during the study period was 862,952, and the number of adverse events involving ST as a suspected drug was 4203. Adverse events associated with ST include hyperkalemia, syndrome of inappropriate antidiuretic hormone secretion, hematopoietic cytopenia, acute renal failure, hypoglycemia, disseminated intravascular coagulation syndrome, hepatic disorder, and the Stevens-Johnson syndrome/toxic epidermal necrolysis. Conclusions: Weibull analysis indicated an early failure-type onset time for all adverse events, suggesting the need for intensive adverse event monitoring of ST, especially in the first month of use. These findings may support revising drug package inserts in Japan to better reflect the identified risks. |
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| 投稿者 | Sagawa, Takaya; Ishida, Tomoaki; Jobu, Kohei; Morisawa, Shumpei; Akagaki, Keita; Kato, Takahiro; Maruyama, Takumi; Yagi, Yusuke; Kihara, Tomomi; Suzuki, Sanae; Endo, Mio; Matsunaga, Nobuaki; Hamada, Yukihiro |
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| 組織名 | Department of Pharmacy, Kochi Medical School Hospital, 185-1 Kohasu, Oko-cho,;Nankoku-shi 783-8505, Kochi, Japan.;Graduate School of Integrated Arts and Sciences, Kochi University, Kohasu,;Oko-cho, Nankoku-shi 783-8505, Kochi, Japan.;Department of Clinical Pharmacy, Graduate School of Pharmaceutical Sciences,;Nagoya City University, 3-1 Tanabe-dori, Mizuho-ku, Nagoya 467-8603, Japan.;Department of Infection Prevention and Control, Kochi Medical School Hospital;;185-1 Kohasu, Oko-cho, Nankoku-shi 783-8505, Kochi, Japan.;Division of Public Health, Department of Planning and Coordination, Bureau of;Health Security and Management, Japan Institute for Health Security, 1-23-1;Toyama, Shinjuku, Tokyo 162-8640, Japan.;Department of Public Health Medicine, Institute of Medicine, and Health Services;Research and Development Center, University of Tsukuba, 1-1-1 Tennodai, Tsukuba;305-8575, Ibaraki, Japan.;AMR Clinical Reference Center, National Center for Global Health and Medicine;Japan Institute for Health Security, 1-21-1 Toyama, Shinjuku, Tokyo 162-8655,;Japan. |
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