Citation

Burns MM, Renny MH. Pediatrics 2021; ePub(ePub): ePub.

Copyright

(Copyright © 2021, American Academy of Pediatrics)

DOI

10.1542/peds.2021-052189

PMID

34607933

Abstract

For more than 10 years, there have been Food and Drug Administration recommendations and manufacturer labeling changes in place advising against the use of cough and cold medications (CCMs) in young children.1,2 In this issue of Pediatrics, Halmo et al3 present concerning findings characterizing fatalities associated with CCMs in recent years. Identifying cases through the Pediatric Cough and Cold Safety Surveillance System and then using an expert panel for review, the authors report 40 CCM-related fatalities in children under 12 years old that occurred from 2008 to 2016. Although overall fatalities associated with CCMs were rare, they found that most fatalities were in children <2 years old and were of nontherapeutic intent, with more than one-half of nontherapeutic intent cases determined to be malicious in nature. Diphenhydramine, a commonly used antihistamine, was found to be the index-ingredient most often involved in CCM-related fatalities. This important fatality review demonstrates that despite safety efforts, young children remain at risk for death from CCMs.

The strengths of the study include the use of a cough-and-cold-specific safety surveillance system that includes data from several national sources and data collection that covered several years after advisory and labeling changes. The surveillance system was limited, however, by self-report and potential misclassification of cases as well as inconsistencies in detailed case information. Autopsy reports were also reviewed, but reports were only available in 55% of cases.3 Therefore, the expert panel could not determine the contributory factors that led to the child's death in almost one-half of fatalities. Thus, these limitations likely have led to an underestimation of CCM-related fatalities and CCM-related fatalities determined to be due to malicious intent, which may occur even more frequently than classified in this study...

Language: en