Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.
Department of Pediatrics, Division of Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
J Pediatric Infect Dis Soc. 2021 May 28;10(5):576-585. doi: 10.1093/jpids/piaa156.
While fluoroquinolones are commonly used in adults, the use in children has been low. Since 2000, there were 3 US Food and Drug Administration (FDA) Boxed warnings regarding fluoroquinolones (2008, 2013, and 2016). Our objective was to describe the use of fluoroquinolones in children and assess the impact of 3 recent FDA warnings on fluoroquinolone use.
From 2000 to 2018, we assessed claims for all outpatient prescription fills to measure the use of systemic fluoroquinolones and other broad-spectrum antibiotics in children less than 18 years old in the MarketScan Commercial Claims and Encounters database. We describe demographics, indication for antibiotic, and clinical characteristics. To assess the impact of FDA warnings on fill rates, we conducted an interrupted time-series analysis.
The cohort included 34.6 million unique beneficiaries less than 18 years old with 441 062 fluoroquinolone fills (5.5 fills per 1000 person-years). The fluoroquinolone fill rate was highest among children > 11 years old. Urinary tract infection was the most common associated diagnosis (21.8%). Since 2008, the fluoroquinolone fill rate has declined. By the end of the study period in December 2018, in the (counterfactual) absence of the FDA warnings, fluoroquinolone fill rate would have been 7.5 (95% confidence interval [CI]: 5.2-9.7); however, the corresponding rate in observed data was 2.8 (95% CI: 1.7-3.9).
Fluoroquinolone use was low compared with other common broad-spectrum antibiotics and declining trends over time were associated with FDA warnings, even though these warnings were not pediatric specific. Future work should assess the adverse events at issue in these warnings in children.
氟喹诺酮类药物在成人中广泛使用，但在儿童中的使用较少。自 2000 年以来，美国食品和药物管理局（FDA）发布了 3 次关于氟喹诺酮类药物的（黑框）警告（2008 年、2013 年和 2016 年）。我们的目的是描述氟喹诺酮类药物在儿童中的使用情况，并评估最近 3 次 FDA 警告对氟喹诺酮类药物使用的影响。
从 2000 年到 2018 年，我们评估了所有门诊处方的索赔，以衡量 MarketScan 商业索赔和就诊数据库中 18 岁以下儿童全身氟喹诺酮类药物和其他广谱抗生素的使用情况。我们描述了人口统计学特征、抗生素的适应证和临床特征。为了评估 FDA 警告对配药率的影响，我们进行了一项中断时间序列分析。
该队列包括 3460 万 18 岁以下的独特受益人群，共进行了 441062 次氟喹诺酮类药物配药（每 1000 人年 5.5 次）。氟喹诺酮类药物的配药率在年龄大于 11 岁的儿童中最高。尿路感染是最常见的相关诊断（21.8%）。自 2008 年以来，氟喹诺酮类药物的配药率一直在下降。在研究期结束时（2018 年 12 月），在没有 FDA 警告的情况下（假设情况），氟喹诺酮类药物的配药率本应达到 7.5（95%置信区间：5.2-9.7）；然而，在观察到的数据中，相应的配药率为 2.8（95%置信区间：1.7-3.9）。
与其他常见的广谱抗生素相比，氟喹诺酮类药物的使用量较低，且随着时间的推移呈下降趋势，这与 FDA 警告有关，尽管这些警告并非专门针对儿童。未来的研究应评估这些警告中涉及的不良事件在儿童中的情况。
