Disproportionality analysis of quinolone safety in children using data from the FDA adverse event reporting system (FAERS)

作者全名："Kong, Wenqiang; Mao, Wei; Zhang, Lin; Wu, Yanyan"

作者地址："[Kong, Wenqiang] Zigong First Peoples Hosp, Dept Pharm, Zigong, Peoples R China; [Mao, Wei] Nanan Peoples Hosp Chongqing, Dept Pharm, Chongqing, Peoples R China; [Zhang, Lin] Third Mil Med Univ, Army Med Univ, Dept Pharm, Southwest Hosp, Chongqing, Peoples R China; [Wu, Yanyan] Chongqing Med Univ, Dept Pharm, Women & Childrens Hosp, Chongqing, Peoples R China; [Wu, Yanyan] Chongqing Hlth Ctr Women & Children, Dept Pharm, Chongqing, Peoples R China"

通信作者："Zhang, L (通讯作者)，Third Mil Med Univ, Army Med Univ, Dept Pharm, Southwest Hosp, Chongqing, Peoples R China.; Wu, YY (通讯作者)，Chongqing Med Univ, Dept Pharm, Women & Childrens Hosp, Chongqing, Peoples R China.; Wu, YY (通讯作者)，Chongqing Hlth Ctr Women & Children, Dept Pharm, Chongqing, Peoples R China."

来源：FRONTIERS IN PEDIATRICS

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000920081500001

JCR分区：Q1

影响因子：2.6

年份：2023

卷号：10

期号：　

开始页：　

结束页：　

文献类型：Article

关键词：drug safety; children; quinolones; pharmacovigilance; disproportionality analysis

摘要："BackgroundQuinolones are widely prescribed for the treatment or prevention of infectious diseases in children. To gain further insight into quinolone-associated adverse event (AE) in children and better protect pediatric patients, continued surveillance of safety data is essential. The purpose of this study was to characterize the safety profiles of quinolone-associated AEs in children by mining the FDA adverse event reporting system (FAERS). MethodsFAERS reports from quarter 1 of 2004 to quarter 1 of 2022 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify adverse events. Reporting odds ratios (ROR) corresponding 95% confidence intervals (CIs) and information component (IC) along with 95% CIs were calculated to detect drug-AE pairs with higher-than-expected reporting rates within the FAERS from System Organ Classes (SOCs) to Preferred Terms (PTs). Reports were considered as signals if the 95% con?dence interval did not contain the null value. ResultsAfter inclusion criteria were applied, a total of 4,704 reports associated with quinolones were considered. Most FAERS reports associated with ciprofloxacin (N = 2,706) followed by levofloxacin (N = 1,191), moxifloxacin (N = 375), oflaxacin (N = 245) and ozenoxacin (N = 187). The most common age group was 12-18 years. The median weight was 39.0 kilogram. The adverse effects of quinolones emerging for SOCs primarily included Infections and infestations, gastrointestinal symptoms, blood and lymphatic system disorders, cardiac disorders, nervous system disorders, musculoskeletal and connective tissue disorders and psychiatric disorders. The most frequently AE signals at the PT level were pyrexia (N = 236), febrile neutropenia (N = 120), off label use (N = 48), drug resistance (N = 18) and cardiac arrest (N = 22) following the use of ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, and ozenoxacin, respectively. Serious oznoxacin-associated AE signals were found and have not been documented in the package insert. They included cardiac arrest (N = 22; ROR = 19.83; IC = 3.68), overdose (N = 21; ROR = 4.98; IC = 2.07), seizure (N = 16; ROR = 6.01; IC = 2.29), small for dates baby (N = 9; ROR = 14.7; IC = 3.05), completed suicide (N = 15, ROR = 18.87; IC = 3.51), asthma (N = 9; ROR = 6.69; IC = 2.24;) and hypotension (N = 9; ROR = 3.83; IC = 1.68). ConclusionThis study provided additional evidence with respect to quinolones-related AEs for children. Generally, the findings of this study are compatible with AEs recorded in package inserts. The unexpected signals of ozenoxacin justify active vigilance by clinicians and timely monitoring by pharmacovigilance experts."

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