In 2008, over-the-counter cough and cold medications (CCMs) underwent labeling changes in response to safety concerns, including fatalities, reported in children exposed to CCMs. The objective of this study is to describe fatalities associated with exposures to CCMs in children <12 years old that were detected by a safety surveillance system from 2008 to 2016.

Fatalities in children <12 years old that occurred between 2008 and 2016 associated with oral exposure to one or more CCMs were identified by the Pediatric Cough and Cold Safety Surveillance System. An expert panel reviewed all cases to determine the causal relationship between the exposure and death, if the intent of exposure was therapeutic, and if the dose was supratherapeutic. Other contributing factors related to the child’s death were also identified as part of a root cause analysis.

Of the 180 eligible fatalities captured during the study period, 40 were judged by the expert panel to be either related or potentially related to the CCM. Of these, the majority (n = 24; 60.0%) occurred in children <2 years old and involved nontherapeutic intent (n = 22; 55.0%). The most frequently involved index ingredient was diphenhydramine (n = 28; 70.0%). In 6 cases (n = 6; 15.0%), the CCM was administered to murder the child. In another 7 cases (n = 7; 17.5%), death followed the intentional use of the CCM to sedate the child.

Pediatric fatalities associated with CCMs occurred primarily in young children after deliberate medication administration with nontherapeutic intent by a caregiver.

2008 年，非处方咳嗽和感冒药 (CCM) 进行了标签更改，以应对安全问题，包括在接触 CCM 的儿童中报告的死亡人数。本研究的目的是描述 2008 年至 2016 年安全监测系统检测到的与接触 CCM 相关的 12 岁以下儿童的死亡人数。

儿科咳嗽和感冒安全监测系统确定了 2008 年至 2016 年期间发生的与口服暴露于一种或多种 CCM 相关的 <12 岁儿童死亡事件。一个专家小组审查了所有病例，以确定暴露与死亡之间的因果关系，暴露的意图是否是治疗性的，以及剂量是否是超治疗性的。与儿童死亡相关的其他促成因素也被确定为根本原因分析的一部分。

在研究期间捕获的 180 名符合条件的死亡事故中，有 40 名被专家小组判断为与 CCM 相关或可能与 CCM 相关。其中，大多数 ( n = 24；60.0%) 发生在 <2 岁且涉及非治疗意图的儿童中 ( n = 22；55.0%)。最常涉及的指标成分是苯海拉明 ( n = 28; 70.0%)。在 6 个案例中（n = 6；15.0%），CCM 被用来谋杀孩子。在另外 7 个案例中（n = 7；17.5%），在故意使用 CCM 镇静儿童之后死亡。

与 CCM 相关的儿科死亡主要发生在照顾者出于非治疗目的故意给药后的幼儿。