Safety of Quinolones in Children: A Systematic Review and Meta-Analysis

Li, Siyu; Chen, Zhe; Huang, Liang; Liu, Zheng; Shi, Yuqing; Zhang, Miao; Li, Hailong; Linan, Zeng; Ni, Jiaqi; Zhu, Yu; Jia, Zhijun; Cheng, Guo; Zhang, Lingli

doi:10.1007/s40272-022-00513-2

Cited by 13 publications

(14 citation statements)

References 116 publications

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“…We found three significant (ciprofloxacin, levofloxacin, and moxifloxacin) signals for vomiting, and two significant signals (ciprofloxacin and levofloxacin) for nausea, abdominal pain, and diarrhoea. Our analysis found a significant signal for abdominal distension with moxifloxacin, which were consistent with a meta-analysis by Li et al ( 13 ) and a similar studies in adults ( 24 , 25 ). A strong signal of arthralgia was elicited from ciprofloxacin and levofloxacin, which were similar to the reported research by Adefurin et al ( 26 ).…”

Section: Discussionsupporting

confidence: 93%

“…In terms of age, 12–18-year-old patients were the most reported age group in our study, which might be related to the higher frequency of quinolone use in this population ( 13 ). FQ-induced tendon disorders were reported to occur tendon ruptures within 1 week of administration and tendinopathies within the first month ( 27 ), Similarly, we observed that the onset of the most frequent FQ-musculoskeletal ADRs was 7 days for the median treatment with ciprofloxacin, 8 days for levofloxacin, 5 days for moxifloxacin and ofloxacin, and 41 days for ozenoxacin.…”

Section: Discussionmentioning

confidence: 69%

“…The proportion of children who experienced musculoskeletal AEs was comparable between the two treatment arms (moxifloxacin group: 4.3%; comparator group: 3.3%) ( 2 ). A recent systematic review including 154,638 children found that the most common AEs associated with systemic quinolones were gastrointestinal reactions such as diarrhea, vomiting, nausea, and abdominal pain ( 13 ). This study also found that the quinolone-treated children had a higher risk of musculoskeletal AEs than those in the comparator group after 2–12 months of follow-up (2–6 months: RR 2.56, 95% CI, 2.26–2.89; 7–12 months: RR 1.35, 95% CI, 0.98–1.86); however, the incidence of musculoskeletal AEs was uncommon and reversible ( 13 ).…”

Section: Introductionmentioning

confidence: 99%

“…A recent systematic review including 154,638 children found that the most common AEs associated with systemic quinolones were gastrointestinal reactions such as diarrhea, vomiting, nausea, and abdominal pain ( 13 ). This study also found that the quinolone-treated children had a higher risk of musculoskeletal AEs than those in the comparator group after 2–12 months of follow-up (2–6 months: RR 2.56, 95% CI, 2.26–2.89; 7–12 months: RR 1.35, 95% CI, 0.98–1.86); however, the incidence of musculoskeletal AEs was uncommon and reversible ( 13 ). Considering the inadequacy of long-term safety studies, the American Academy of Pediatrics (AAP) has recommended FQ use in children only when no effective and safe alternative is available ( 7 ).…”

Section: Introductionmentioning

confidence: 99%

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

Kong

Mao²,

Zhang³

et al. 2023

Front. Pediatr.

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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% conﬁdence 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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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 69%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Kong

Mao²,

Zhang³

et al. 2023

Front. Pediatr.

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“…Fluorochinolones are one of the recommended antimicrobial groups in empirical UTI treatment for adults. The use of these antibiotics in children is not recommended due to their toxic effect on chondrocytes, which was proven in studies on juvenile animals [ 33 ]. In our study, we used the norfloxacin disc as the screening method for fluoroquinolones susceptibility testing.…”

Section: Discussionmentioning

confidence: 99%

Antibiotic Resistance of Enterococcus spp. Isolated from the Urine of Patients Hospitalized in the University Hospital in North-Central Poland, 2016–2021

et al. 2022

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Urinary Tract Infections (UTIs) are common outpatient and inpatient infections, often treated with empirical therapy. Enterococcus spp. is responsible for about 10% of UTIs. This study aimed to determine the necessity of changing the empirical treatment of UTIs caused by Enterococcus spp. The evaluation was performed for 542 Enterococcus strains isolated from urine samples in the years 2016–2021. We identified three Enterococcus species that were found: E. faecalis (389, 71.8%), E. faecium (151, 27.8%) and E. gallinarum (2, 0.4%). E. faecalis was the dominant species every year. Among E. faecalis, the most prevalent was resistance to norfloxacin (51.4%). Almost all E. faecium strains (150, 99.3%) were resistant to beta-lactams and norfloxacin. Eighty-three strains (55.0%) were resistant to vancomycin and 72 (47.7%) to teicoplanin. E. faecium strains showed a significantly higher percentage of resistance mechanisms GRE (Glicopeptide-Resistant Enterococcus) (72, 48.7%) and VRE (Vancomycin-Resistant Enterococcus) (11, 7.3%), while only five strains of E. feacalis showed a VRE mechanism (1.3%). In the therapy of E. faecalis UTIs, ampicillin and imipenem still remain effective. However, the above-mentioned antibiotics, as well as fluoroquinolones, are not recommended in the treatment of UTIs of E. faecium etiology.

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Personalized application of antimicrobial drugs in pediatric patients with augmented renal clearance: a review of literature

Xu,

Qu,

Teng

et al. 2023

Eur J Pediatr

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Safety of Quinolones in Children: A Systematic Review and Meta-Analysis

Cited by 13 publications

References 116 publications

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

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

Antibiotic Resistance of Enterococcus spp. Isolated from the Urine of Patients Hospitalized in the University Hospital in North-Central Poland, 2016–2021

Personalized application of antimicrobial drugs in pediatric patients with augmented renal clearance: a review of literature

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