アブストラクト | Drug-associated kidney injury is related to longer hospitalization and increased risk of chronic kidney disease and mortality. However, there is currently a lack of large population studies on drug-associated kidney injury in children. This study aimed to study perform data mining to generate hypotheses on drugs, which may deserve to be assessed as per their potential risk of increasing kidney injury in children. We extracted and analyzed reports on drugs associated with kidney injury in children in the FDA Adverse Event Reporting System (FAERS). We conducted a disproportionality analysis using proportional reporting ratio (PRR) to evaluate the association between drugs and kidney injury in children. Meanwhile, comparisons were performed with drug labels to identify drugs that, despite not having kidney injury currently mentioned in their labels, may potentially be associated with risks of kidney injury in children. A total of 6347 children had drug-associated kidney injury in the FAERS database. The top five drugs with the highest PRR were gentamicin (PRR = 12.28, N = 157 cases, Chi-Squared = 1602.77), piperacillin-tazobactam (PRR = 9.77, N = 129 cases, Chi-Squared = 1003.24), amlodipine (PRR = 8.98, N = 271 cases, Chi-Squared = 1861.46), vancomycin (PRR = 8.91, N = 295 cases, Chi-Squared = 1998.64), and ceftriaxone (PRR = 8.00, N = 251 cases, Chi-Squared = 1494.02). According to drug labels, 9 drugs (9/30) were classified as potential nephrotoxins. CONCLUSIONS: Approximately one-third of drugs associated with kidney injury in children do not list kidney injury as a side effect in their drug labels. Future studies are therefore warranted to evaluate whether these drugs are associated with such a risk. WHAT IS KNOWN: * Nephrotoxic drugs are an increasingly common cause of acute kidney injury in hospitalized children. * Currently, no study has systematically combed drugs associated with kidney injury in children. WHAT IS NEW: * Approximately a third of drugs showing signals for potential kidney injury in children in data mining do not mention this side effect in their drug labels. * This study provides data on drugs needing further study to determine whether they might increase the risk of kidney injury in children. |
投稿者 | Zhang, Miao; Li, Hailong; Huang, Liang; Liu, Yan; Jiao, Xue-Feng; Zeng, Linan; Jia, Zhi-Jun; Cheng, Guo; Zhang, Lingli; Zhang, Wei |
組織名 | Department of Pharmacy, West China Second University Hospital, Sichuan;University, Chengdu, China.;Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan;NMPA Key Laboratory for Technical Research On Drug Products In Vitro and In Vivo;Correlation, Chengdu, China.;Key Laboratory of Birth Defects and Related Diseases of Women and Children,;Ministry of Education, Sichuan University, Chengdu, China.;West China School of Pharmacy, Sichuan University, Chengdu, China.;Department of Pediatrics, West China Second University Hospital, Sichuan;Laboratory of Molecular Translational Medicine, Center for Translational;Medicine, Sichuan University, Chengdu, China.;West China Biomedical Big Data Center, West China Hospital, Sichuan University,;Chengdu, China. zhanglingli@scu.edu.cn.;Medical Big Data Center, Sichuan University, Chengdu, China.;zhanglingli@scu.edu.cn.;University, Chengdu, China. zhangwei@wchscu.cn.;Correlation, Chengdu, China. zhangwei@wchscu.cn.;Ministry of Education, Sichuan University, Chengdu, China. zhangwei@wchscu.cn.;Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University,;Chengdu, China. zhangwei@wchscu.cn. |