Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Office of Pharmaceutical Quality, Office of Biotechnology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
J Clin Pharmacol. 2023 Nov;63 Suppl 2:S18-S24. doi: 10.1002/jcph.2305.
Pediatric obesity is a global public health concern. Obesity-related physiological changes may affect the pharmacokinetics of drugs and lead to therapeutic failure or toxicities. An earlier review of pediatric drug development programs from 2007 to 2016 found that, of 89 programs listing obesity-related terms, only 4 (4%) products described pharmacokinetic changes associated with obesity. This review examined obesity considerations for 185 drug products for which pediatric drug development programs were submitted to the US Food and Drug Administration (FDA) between 2016 and 2021. The FDA-authored review documents and drug product labeling were queried for obesity-related terms and the review found 97/185 (52%) drug products had obesity-related terms in these sources. Of the 97 drug products, 55/97 (57%) had obesity-related terms in the FDA-authored reviews only, 13/97 (13%) had obesity-related terms in the drug product labeling only, and 29/97 (30%) had obesity-related terms in both FDA-authored reviews and drug product labeling. Most of the obesity-related information in the drug product labeling originated from data collected from adults. Only 13/185 (7%) drug product labeling contained obesity-related terms in reference to drug pharmacokinetics. Specific dosage recommendations for the use of the drug products in pediatric patients who are obese remain lacking. The dearth of available information to guide drug dosages in the obese pediatric population suggests that further research, innovative approaches, and evidence-based guidelines are needed to inform the optimal therapeutic use of drugs in this population.
儿科肥胖是一个全球性的公共卫生问题。肥胖相关的生理变化可能会影响药物的药代动力学，导致治疗失败或毒性。对 2007 年至 2016 年期间的儿科药物开发计划进行的早期审查发现，在列出与肥胖相关术语的 89 个计划中，只有 4 个（4%）产品描述了与肥胖相关的药代动力学变化。本综述审查了在 2016 年至 2021 年期间向美国食品和药物管理局（FDA）提交儿科药物开发计划的 185 种药物产品，这些产品考虑了肥胖因素。对 FDA 撰写的审查文件和药物产品标签进行了与肥胖相关的术语查询，审查发现 185 种药物中有 97/185（52%）种药物在这些来源中有与肥胖相关的术语。在这 97 种药物中，55/97（57%）种药物仅在 FDA 撰写的审查中有与肥胖相关的术语，13/97（13%）种药物仅在药物产品标签中有与肥胖相关的术语，29/97（30%）种药物在 FDA 撰写的审查和药物产品标签中均有与肥胖相关的术语。药物产品标签中与肥胖相关的大部分信息均来源于从成人收集的数据。只有 13/185（7%）种药物产品标签中包含与药物药代动力学相关的与肥胖相关的术语。对于肥胖儿科患者使用这些药物产品的具体剂量建议仍然缺乏。缺乏可用信息来指导肥胖儿科人群的药物剂量，这表明需要进一步研究、创新方法和基于证据的指南，以指导该人群中药物的最佳治疗应用。
