Siyu Li1,2,3,4, Zhe Chen1,2,3, Liang Huang1,2,3, Zheng Liu1,2,3,4, Yuqing Shi1,2,3,5, Miao Zhang1,2,3,5, Hailong Li1,2,3, Linan Zeng1,2,3, Jiaqi Ni1,2,5, Yu Zhu6, Zhi-Jun Jia1,2,3,5, Guo Cheng3,6,7, Lingli Zhang8,9,10. 1. Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, 610041, China. 2. Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, 610041, China. 3. Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Chengdu, 610041, China. 4. West China School of Medicine, Sichuan University, Chengdu, 610041, China. 5. West China School of Pharmacy, Sichuan University, Chengdu, 610041, China. 6. Department of Pediatrics, West China Second University Hospital, Sichuan University, Chengdu, 610041, China. 7. Laboratory of Molecular Translational Medicine, Center for Translational Medicine, Sichuan University, Chengdu, 610041, China. 8. Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, 610041, China. zhanglingli@scu.edu.cn. 9. Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, 610041, China. zhanglingli@scu.edu.cn. 10. Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Chengdu, 610041, China. zhanglingli@scu.edu.cn.
Abstract
BACKGROUND: The results of animal experiments show that quinolone antibacterial drugs may permanently damage the soft tissues of the weight-bearing joints of young animals. Out of safety concerns, using quinolones in children has always been controversial. OBJECTIVE: The aim of this study was to assess the risk of using quinolones in children and provide evidence for clinicians to support decision making. DATA SOURCES: The MEDLINE (Ovid), EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), International Pharmaceutical Abstracts (Ovid), CINAHL, CNKI, VIP, and WanFang Data databases were searched from inception to 8 September 2021. STUDY SELECTION: All types of studies that reported the safety data of quinolones in children, including clinical trials and observational studies. DATA EXTRACTION: Data extraction and cross-checking were completed by two independent reviewers using a pilot-tested standardized data extraction form. RESULTS: The overall incidence rate of adverse drug events (ADEs) in children using systemic quinolones was 5.39% and the most common ADEs were gastrointestinal reactions (incidence rate, 2.02%). Quinolone-induced musculoskeletal ADEs in children were uncommon (0.76%). Meta-analysis results showed that the risk of musculoskeletal ADEs in children using quinolones was higher than children in the control group (51 studies; rate ratio [RR] 2.03, 95% confidence interval [CI] 1.82-2.26; p < 0.001; I2 = 18.6%; moderate-quality evidence). However, the subgroup analysis results showed that differences might only be observed in children who were followed up for 2 months to 1 year (2-6 months: RR 2.56, 95% CI 2.26-2.89; 7 months to 1 year: RR 1.35, 95% CI 0.98-1.86). Moreover, children (adolescents) aged between 13 and 18 years might be sensitive to the musculoskeletal toxicity of quinolones (RR 2.69, 95% CI 2.37-3.05; moderate-quality evidence) and the risk of levofloxacin-induced musculoskeletal ADEs might be higher (RR 1.33, 95% CI 1.00-1.77; low-quality evidence). CONCLUSIONS: Although the existing evidence shows that quinolone-induced musculoskeletal ADEs seem to be only short-term and reversible, and no serious skeletal and muscular system damage cases have been reported in children, quinolones should be avoided unless necessary in children because the incidence rate of quinolone-related ADEs is not low and they are broad-spectrum antibiotics that will induce the emergence of resistant strains if used frequently.
BACKGROUND: The results of animal experiments show that quinolone antibacterial drugs may permanently damage the soft tissues of the weight-bearing joints of young animals. Out of safety concerns, using quinolones in children has always been controversial. OBJECTIVE: The aim of this study was to assess the risk of using quinolones in children and provide evidence for clinicians to support decision making. DATA SOURCES: The MEDLINE (Ovid), EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), International Pharmaceutical Abstracts (Ovid), CINAHL, CNKI, VIP, and WanFang Data databases were searched from inception to 8 September 2021. STUDY SELECTION: All types of studies that reported the safety data of quinolones in children, including clinical trials and observational studies. DATA EXTRACTION: Data extraction and cross-checking were completed by two independent reviewers using a pilot-tested standardized data extraction form. RESULTS: The overall incidence rate of adverse drug events (ADEs) in children using systemic quinolones was 5.39% and the most common ADEs were gastrointestinal reactions (incidence rate, 2.02%). Quinolone-induced musculoskeletal ADEs in children were uncommon (0.76%). Meta-analysis results showed that the risk of musculoskeletal ADEs in children using quinolones was higher than children in the control group (51 studies; rate ratio [RR] 2.03, 95% confidence interval [CI] 1.82-2.26; p < 0.001; I2 = 18.6%; moderate-quality evidence). However, the subgroup analysis results showed that differences might only be observed in children who were followed up for 2 months to 1 year (2-6 months: RR 2.56, 95% CI 2.26-2.89; 7 months to 1 year: RR 1.35, 95% CI 0.98-1.86). Moreover, children (adolescents) aged between 13 and 18 years might be sensitive to the musculoskeletal toxicity of quinolones (RR 2.69, 95% CI 2.37-3.05; moderate-quality evidence) and the risk of levofloxacin-induced musculoskeletal ADEs might be higher (RR 1.33, 95% CI 1.00-1.77; low-quality evidence). CONCLUSIONS: Although the existing evidence shows that quinolone-induced musculoskeletal ADEs seem to be only short-term and reversible, and no serious skeletal and muscular system damage cases have been reported in children, quinolones should be avoided unless necessary in children because the incidence rate of quinolone-related ADEs is not low and they are broad-spectrum antibiotics that will induce the emergence of resistant strains if used frequently.
Authors: Matthew Neame; Charlotte King; Andrew Riordan; Anand Iyer; Rachel Kneen; Ian Sinha; Daniel B Hawcutt Journal: Eur J Hosp Pharm Date: 2019-01-28