Johann-Liang Rosemary, Wyeth Jo, Chen Min, Cope Judith U
Health Resources and Services Administration, Department of Health and Human Services, Rockville, MD 20857, USA.
Pharmacoepidemiol Drug Saf. 2009 Jan;18(1):24-7. doi: 10.1002/pds.1679.
Our objective was to examine the numbers and characteristics of US pediatric adverse events (AEs) reported to the Food and Drug Administration (FDA)'s adverse event reporting system (AERS) for 5 years following implementation of the Best Pharmaceuticals for Children Act (BPCA) in 2002.
We analyzed reports in AERS received by FDA from January 1, 2003 to January 1, 2008 for overall numbers, age, gender, and seriousness of outcome in children and adults. Pediatric and adult age groups (<2, 2-10, 11-17, 18-50, and >50 years of age) were further evaluated for most frequently reported suspect drug classes and AEs.
Seventy-two percent of 815 267 crude count reports had specified age information. Six percent of the total reports with age information reported age <18 years. Numbers of AEs being reported for children have remained steady, while those for adults have increased. The proportion of serious AEs reported was similar for pediatrics as compared to adults. Frequently reported suspect drug classes noted in pediatric age groups that were not observed in adults included anticonvulsants, attention deficit hyperactivity disorder (ADHD), anti-acne, and respiratory medications.
This overview highlights the need for strengthening the passive drug surveillance system from a pediatric perspective, as well as investing in more active surveillance systems. Drug safety initiatives to better capture risk information in order to balance the risk/benefit of drug use in children.
我们的目标是研究自2002年《儿童最佳药品法案》（BPCA）实施后的5年里，向美国食品药品监督管理局（FDA）不良事件报告系统（AERS）报告的美国儿科不良事件（AE）的数量及特征。
我们分析了FDA在2003年1月1日至2008年1月1日期间收到的AERS报告，内容包括儿童和成人的总体数量、年龄、性别以及结局的严重程度。对儿科和成人年龄组（<2岁、2 - 10岁、11 - 17岁、18 - 50岁和>50岁）进一步评估最常报告的可疑药物类别和不良事件。
815267份原始计数报告中有72%包含特定年龄信息。在有年龄信息的报告总数中，6%报告的年龄<18岁。儿童报告的不良事件数量保持稳定，而成人报告的不良事件数量有所增加。儿科报告的严重不良事件比例与成人相似。儿科年龄组中经常报告但在成人中未观察到的可疑药物类别包括抗惊厥药、注意力缺陷多动障碍（ADHD）药物、抗痤疮药和呼吸系统药物。
本综述强调了从儿科角度加强被动药物监测系统的必要性，以及投资建立更积极的监测系统。采取药物安全举措以更好地获取风险信息，从而平衡儿童用药的风险/效益。
