Background and Objectives: The aim of this study is to investigate the characteristics of gastrointestinal bleeding events associated with BCR-ABL tyrosine kinase inhibitor (TKI) treatment, using the reporting odds ratio (ROR) of the adverse event reports submitted to the Japanese Adverse Drug Event Report database between 2004 and 2020, and to examine the number of reported TKI-related gastrointestinal bleeding cases according to sex and age, as well as the actual number of TKI prescriptions issued in Japan. Materials and Methods: The RORs and 95% confidence intervals (CIs) of gastrointestinal bleeding events related to TKIs were calculated using the data of the 595,121 included cases. Results: Significant gastrointestinal bleeding events were detected for dasatinib (crude ROR: 4.47, 95% CI: 3.77–5.28) and imatinib (crude ROR: 1.22, 95% CI: 1.01–1.46). In multiple logistic regression analyses, significant gastrointestinal bleeding events were detected for dasatinib (adjusted ROR: 8.02, 95% CI: 5.75–10.2), imatinib (adjusted ROR: 1.81, 95% CI: 1.2–2.72), age (≥60 years, adjusted ROR: 2.22, 95% CI: 2.1–2.36), reporting year (adjusted ROR: 1.04, 95% CI: 1.04–1.05), and male sex (adjusted ROR: 1.47, 95% CI: 1.37–1.57). Interaction analysis revealed that the association of gastrointestinal bleeding with dasatinib was affected by age (≥60 years) and sex (female), with the number and proportion of dasatinib-related gastrointestinal bleeding cases increasing among those aged ≥60 years. Conclusions: Specific TKIs and patient characteristics were associated with gastrointestinal bleeding. Our results aid the prompt identification and treatment of TKI-related gastrointestinal bleeding.

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.

Background and Objectives: Hyponatremia is among the most prevalent electrolyte abnormalities observed in patients with cancer during chemotherapy. Therefore, managing hyponatremia is crucial since it causes a severe electrolyte imbalance that can lead to significant mortality, and this study aimed to investigate the relationship between hyponatremia, anticancer drugs, and cancer types. Materials and Methods: Reported odds ratios were calculated and evaluated based on adverse event reports submitted to the Japanese Adverse Drug Event Report (JADER) database. Results: Overall, 2943 patients had hyponatremia. Notably, cisplatin, pemetrexed, and etoposide had marked hyponatremia signals. In addition, significant hyponatremia signals were detected for oesophageal, lung, and renal cancers. Conclusions: Hyponatremia has been reported in women and patients with lung cancer receiving cisplatin, with a growing trend in the number of elderly patients receiving cisplatin. Furthermore, since the onset of hyponatremia during cisplatin administration is frequently reported within 10 days, patient information should be thoroughly examined before and monitored throughout the administration, which can contribute to the early detection and prevention of hyponatremia.

Background/Objectives: Cisplatin is used as treatment for various malignant tumors; nevertheless, this anticancer drug frequently causes side effects such as renal damage and hypomagnesemia. Hypomagnesemia has been suggested to cause renal damage, and preventing hypomagnesemia through magnesium supplementation is necessary to continue treatment while maintaining treatment intensity. Although the usefulness of magnesium supplementation has been previously evaluated, problems with the amount of magnesium supplementation and sample size have been identified. This study aimed to examine the usefulness and amount of magnesium supplementation by conducting a meta-analysis of a large number of studies. Methods: This meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines. Relevant studies published in PubMed, Scopus, Ichushi, and Cochrane Library databases from inception to 31 December 2025 were selected. The searched text combinations were “cisplatin” and “magnesium.” Results: Magnesium supplementation showed an inhibitory effect on cisplatin-induced renal injury. The inhibitory effect of magnesium supplementation showed no difference among the three dose groups (<10 mEq, 10–<20 mEq, and ≥20 mEq). Conclusions: Magnesium supplementation is useful for preventing cisplatin-induced nephrotoxicity, irrespective of its dose. The results of this meta-analysis may be clinically helpful in preventing hypomagnesemia-induced nephrotoxicity and continuing treatment.