Detection and Analysis of Safety Signals of Chloroquine Based Upon FDA Adverse Event Database
HU Xi1,2, HONG Dong-sheng1,2, YANG Hong-yu1,2, ZHENG Dong-sheng1,2, ZHAO Qing-wei1,2*
1. The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310003, China; 2. Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, Hangzhou 310003, China
Abstract：OBJECTIVE To analyze and evaluate the safety signals of chloroquine in the patients, and to provide a valuable reference for rational use in clinic. METHODS Both the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) were applied to analyze safety signals of chloroquine based upon the adverse drug events (ADEs) data ranging from 2004 to 2020 as reported in the Adverse Event Reporting System (FAERS) database of the Food and Drug Administration (FDA), and to systematically assesse the safety signals of chloroquine phosphate on various organs systems. RESULTS Among the 2 063 reports of ADEs studied, 557 reports were considered to be mainly caused by chloroquine. The results demonstrated that the high-risk ADEs signals of chloroquine involved various systems, such as atrioventricular block complete (ROR=2.90, IC-2SD=1.64), ventricular fibrillation (ROR=3.40, IC-2SD=1.27), blindness (ROR=27.51, IC-2SD=0.55), cardiogenic shock (ROR=6.86, IC-2SD=0.54), vomiting (ROR=1.70, IC-2SD=1.83). Moreover, some rare ADEs with high-risk signals showed a correlation with chloroquine, including hypokalaemia (ROR=4.18,IC-2SD=1.51), renal failure acute (ROR=3.08, IC-2SD=0.30), methaemoglobinaemia (ROR=4.37, IC-2SD=0.03), and pyrexia (ROR=1.80, IC-2SD=1.84), which were consistent with literature reports. However, these ADEs were not listed in instruction and worth much attention in clinic. Moreover, basic diseases of patients and drug incompatibility need much attention to prevent the occurrence and exacerbation of chloroquine-related adverse reactions. CONCLUSION A comprehensive analysis of the ADEs signals of chloroquine could shed some light on understanding of its safety characteristics and would provide valuable information for rational use of chloroquine in clinic, especially in treatment of COVID-19.
胡希, 洪东升, 羊红玉, 郑东升, 赵青威. 基于FDA数据库对氯喹不良反应信号的检测及药物相互作用分析[J]. 中国药学杂志, 2020, 55(9): 685-691.
HU Xi, HONG Dong-sheng, YANG Hong-yu, ZHENG Dong-sheng, ZHAO Qing-wei. Detection and Analysis of Safety Signals of Chloroquine Based Upon FDA Adverse Event Database. Chinese Pharmaceutical Journal, 2020, 55(9): 685-691.
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2020, Vol. 55 
