a Pediatrics & Public Health Sciences , Penn State College of Medicine , Hershey , PA , USA.
b Rocky Mountain Poison and Drug Center , Denver Health and Hospital Authority , Denver , CO , USA.
Clin Toxicol (Phila). 2018 Nov;56(11):1162-1164. doi: 10.1080/15563650.2018.1459665. Epub 2018 Apr 10.
Until recently most of the scrutiny of opioid-containing cough and cold medications (CCMs) by the US Food and Drug Administration (FDA) was focused on codeine, only recently shifting equal focus to those containing hydrocodone. We characterized adverse events (AEs) in children <12 years old associated with CCMs that include both an opioid and over-the-counter (OTC) ingredient.
US cases from multiple sources collected as part of a safety surveillance program were included if AEs followed exposure to combination CCMs containing codeine or hydrocodone between January 2008 and December 2015. An expert panel reviewed cases to identify causal relationship between exposure and AEs and identify contributing factors. Each AE term was coded using the Medical Dictionary for Regulatory Activities with preferred terms reported.
One hundred and fourteen of the 7035 (2%) cases reviewed involved an opioid-containing product. Ninety-eight cases involved an AE at least potentially related to the opioid ingredient (38 (39%) codeine; 60 (61%) hydrocodone). All three fatality cases involved hydrocodone with an antihistamine. Among non-fatalities, somnolence, lethargy, and/or respiratory depression were more commonly reported among hydrocodone cases than codeine cases (86% vs. 61%; p = .005).
These safety surveillance data support the FDA's expanded label changes limiting opioid CCMs for children.
直到最近，美国食品和药物管理局 (FDA) 对含阿片类药物的咳嗽和感冒药 (CCM) 的审查主要集中在可待因上，最近才将同样的重点转移到含有氢可酮的药物上。我们描述了 12 岁以下儿童使用含阿片类药物和非处方 (OTC) 成分的 CCM 后出现的不良事件 (AE)。
如果在 2008 年 1 月至 2015 年 12 月期间，儿童在接触含有可待因或氢可酮的复方 CCM 后出现 AE，来自多个来源的美国病例将被纳入作为安全监测计划的一部分。一个专家小组审查了这些病例，以确定暴露与 AE 之间的因果关系，并确定促成因素。每个 AE 术语均使用监管活动医学词典进行编码，并报告首选术语。
在审查的 7035 例病例中，有 114 例 (2%) 涉及含阿片类药物的产品。98 例涉及至少与阿片类药物成分相关的 AE (38 例 [39%] 为可待因；60 例 [61%] 为氢可酮)。所有 3 例死亡病例均涉及含有抗组胺药的氢可酮。在非致死性病例中，与可待因病例相比，氢可酮病例更常报告嗜睡、昏睡和/或呼吸抑制 (86% vs. 61%；p = .005)。
这些安全监测数据支持 FDA 扩大标签变更，限制儿童使用含阿片类药物的 CCM。
