Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd, NE, Mailstop A-24, Atlanta, GA 30333, USA.
Pediatrics. 2010 Dec;126(6):1100-7. doi: 10.1542/peds.2010-1839. Epub 2010 Nov 22.
A voluntary market withdrawal of orally administered, over-the-counter, infant cough and cold medications (CCMs) was announced in October 2007. The goal of this study was to assess CCM-related adverse events (AEs) among children after the withdrawal.
Emergency department (ED) visits for CCM-related AEs among children <12 years of age were identified from a nationally representative, stratified, probability sample of 63 US EDs, for the 14 months before and after announcement of withdrawal.
After withdrawal, the number and proportion of estimated ED visits for CCM-related AEs involving children <2 years of age were less than one-half of those in the prewithdrawal period (1248 visits [13.3%] vs 2790 visits [28.7%]; difference: -15.4% [95% confidence interval [CI]: -25.9% to -5.0%]), whereas the overall number of estimated ED visits for CCM-related AEs for children <12 years of age remained unchanged (9408 visits [95% CI: 6874-11 941 visits] vs 9727 visits [95% CI: 6649-12 805 visits]). During both periods, two-thirds of estimated ED visits involved unsupervised ingestions (ie, children finding and ingesting medications).
ED visits for CCM-related AEs among children <2 years of age were substantially reduced after withdrawal of over-the-counter infant CCMs. Further reductions likely will require packaging improvements to reduce harm from unsupervised ingestions and continued education about avoiding CCM use for young children. Monitoring of CCM-related harm should continue because recommendations were updated in October 2008 to avoid the use of CCMs for children <4 years of age.
2007 年 10 月，宣布自愿撤回市售的、非处方的、口服婴幼儿咳嗽和感冒药物（CCM）。本研究的目的是评估撤回后儿童与 CCM 相关的不良事件（AE）。
从全国代表性的、分层的、概率抽样的 63 个美国急诊室中，确定了 12 岁以下儿童与 CCM 相关 AE 的急诊室就诊情况，时间为撤回前和撤回后 14 个月。
撤回后，2 岁以下儿童与 CCM 相关 AE 的估计急诊就诊数量和比例不到撤回前的一半（1248 次就诊[13.3%]与 2790 次就诊[28.7%]；差异：-15.4%[95%可信区间（CI）：-25.9%至-5.0%]），而 12 岁以下儿童与 CCM 相关 AE 的总体估计急诊就诊数量保持不变（9408 次就诊[95%CI：6874-11941 次就诊]与 9727 次就诊[95%CI：6649-12805 次就诊]）。在两个时期，三分之二的估计急诊就诊涉及无人监督的摄入（即，儿童发现和摄入药物）。
撤回非处方婴幼儿 CCM 后，2 岁以下儿童与 CCM 相关 AE 的急诊就诊显著减少。进一步减少可能需要改进包装，以减少无人监督摄入造成的伤害，并继续教育避免幼儿使用 CCM。应继续监测 CCM 相关伤害，因为 2008 年 10 月更新了建议，避免 4 岁以下儿童使用 CCM。
