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Objective: Several medications are associated with delirium; however, studies with adequate statistical power are limited, and it is difficult to determine the effects of the various concomitant medications used in clinical practice. Therefore, in this study, we aimed to comprehensively evaluate the safety signals of delirium-associated drugs using a spontaneous adverse event reporting system., Method: The JAPIC AERS (Food and Drug Administration Adverse Event Reporting System pre-processed by the Japan Pharmaceutical Information Center) was used for the analysis in this pharmacovigilance study. The reporting odds ratio (ROR) for delirium was adjusted for using multivariate logistic regression analysis with sex, age, indication, and melatonin receptor agonist use, and 22 drug categories were targeted as covariates., Results: After excluding patients with missing information, 7,527,568 patients were included in the study. Delirium signals were detected even after adjusting for covariates in 17 drug categories, including benzodiazepines (adjusted ROR, 1.76; 95% confidence interval [CI], 1.64-1.89), opioids (adjusted ROR, 4.42; 95% CI, 4.21-4.64), and tricyclic antidepressants (adjusted ROR, 2.44; 95% CI, 2.20-2.71)., Conclusions: These findings suggest that many drug classes, such as benzodiazepines, are independent risk factors for delirium and strengthen the evidence of an association between delirium and medications., Competing Interests: Declaration of competing interest The authors declare no conflict of interest. The interests over the past three years are as follows: MH received honoraria from Ishiyaku Publishers, Inc., Meiji Seika Pharma Co., Ltd., Medical Friend. Co., Ltd., Nanzando Co., Ltd., Sumitomo Pharma Co., Ltd., and WELCIA Holdings Co., Ltd. RS received honoraria from Eisai Co., Ltd., Meiji Seika Pharma Co., Ltd., Merck & Co., Inc., Nippon Kayaku Co.,Ltd., Novartis Pharma K.K., Otsuka Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Factory, and Sumitomo Pharma Co., Ltd. KS received honoraria from Eisai Co., Ltd. SE received honoraria from Eisai Co., Ltd. AI received honoraria from Sumitomo Pharma Co., Ltd. and UCB Japan Co. Ltd. RM received honoraria from Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., and UCB Japan Co. Ltd. HA received honoraria from Sumitomo Pharma Co., Ltd. SY received honoraria from AstraZeneca K.K., Daiichi Sankyo Co., Ltd., EA Pharma Co., Ltd., Eisai Co., Ltd., Meiji Seika Pharma Co., Ltd., Nippon Shinyaku Co., Ltd., Nipro Corporation, Otsuka Pharmaceutical Factory, Pfizer Japan Inc., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Toa Eiyo Ltd., and Towa Pharmaceutical Co., Ltd. Funding was received from EA Pharma Co., Ltd., Kissei Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., SUGI Holdings Co., Ltd., and Otsuka Pharmaceutical Factory., (Copyright © 2024 Elsevier Inc. All rights reserved.)

The aim of the study was to investigate the incidence of and risk factors for de novo malignancy after heart transplantation (HTx) in a single center. We assessed 102 consecutive patients who received HTx and were followed-up in our center regularly for > 1 year from June 2006 to May 2018. We investigated the incidence of and risk factors for de novo malignancy. The cumulative incidence of each malignancy type during the follow-up period was one (0.98%) for skin cancer, four (3.92%) for nonskin solid organ cancer, and six (5.88%) for posttransplant lymphoproliferative disorder (PTLD). The percentage of patients with more than one infectious event ≤ 1 year after HTx was higher in the malignancy group than in the non-malignancy group. Furthermore, Kaplan-Meier analysis revealed that the incidence rate of infectious events was higher in patients with malignancies than in those without (log-rank P < 0.001). After dividing malignancies into a PTLD group and a solid organ malignancy group, we found that negative Epstein-Barr virus serostatus, cytomegalovirus-positive antigenemia, and the occurrence of any viral or gastrointestinal infectious event at ≤ 1 year were more frequent in patients with PTLD than in patients without it. The survival rate was significantly lower for patients with solid organ malignancy than for patients without malignancy. In conclusion, there was a correlation between infectious events and de novo malignancy, particularly in patients with PTLD. We should confirm this finding by conducting a larger cohort study.