In 2008, the Food and Drug Administration (FDA) recommended that over-the-counter (OTC) cough and cold medications (CCMs) not be used in children under 2 years of age due to concerns regarding safety and efficacy. Manufacturers of these products voluntarily responded by labeling these products as not to be used by children under 4 years old. Since then, how often have these products been used in younger children leading to death?
To answer that question, Halmo et al (10.1542/peds.2020-049536) analyzed data from 2008 to 2016 in the Pediatric Cough and Cold Safety Surveillance System, a national data repository that collects fatality data from poison center registries, the FDA, news/media reports, and safety reports from CCM manufacturers. Fatal cases were then reviewed by an expert panel to determine if there was a causal relationship between the CCM and the death. Of the almost 8,000 cases of adverse events from CCM exposure in children studied, 180 of these cases were associated with death. Tragically, of these deaths, 40 were judged to be related or potentially related to a CCM, including 24 among children under 2 years of age. Even more concerning, 22 of the 40 cases involved non-therapeutic intent—meaning to sedate or murder a child. If you want to know what agents were most often involved in CCM-related fatalities, the authors share that data as well (diphenhydramine being the most frequently involved ingredient).
The surveillance system used for data analysis in this study included a complex surveillance process instead of systematic population-level monitoring and may have misclassified the cause of fatality since not every case had an autopsy performed. An accompanying commentary by Drs. Michele Burns from Boston Children’s Hospital and Madeline Renny from New York University (10.1542/peds.2021-052189) will convince you that the findings may underestimate the harm associated with CCM. The commentary also helps us better understand why these fatalities continue to occur and what may be contributing to the use of CCMs for non-therapeutic intent. The authors of both the study and commentary identify factors unique to fatal and non-fatal adverse events associated with CCMs and what we can do to target preventive interventions in caregivers who reflect high risk attributes for using a CCM in their child, especially a young child. The information in this study and commentary are a bitter pill to swallow especially when we hoped to see no fatalities after CCMs underwent label changes to avoid their use in young children. This study suggests we have more work to do. Link to this study and commentary to see just what that work might entail.