Over-the-Counter Cough and Cold Medications Danger in Children

Abstract

Source: Halmo LS, Wang GS, Reynolds KM, et al. Pediatric fatalities associated with over-the-counter cough and cold medications [published online ahead of print October 4, 2021]. Pediatrics. 2021: e2020049536; doi.10.1542/peds.2020-049536Investigators from multiple institutions conducted a study to describe fatalities due to ingestion of cough and cold medications (CCMs) in children following a 2008 FDA recommendation to not use these products in children <2 years old and a labelling change by drug manufacturers to not use in children <4 years old. Cases were identified by the Pediatric Cough and Cold Safety Surveillance System that collected data on ingestions from multiple sources, including poison control centers, FDA reporting systems, and media reports. Cases were children <12 years old who died after oral exposure to 1 or more of 8 index ingredients (brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, phenylephrine, or pseudoephedrine) between 2008 and 2016. All case data available and autopsy reports were reviewed by an expert panel that classified identified fatalities as related, potentially related, or unrelated to CCMs; some cases could not be classified. The primary study outcome was a fatality related or potentially related to CCMs. Deaths were judged to be from therapeutic, nontherapeutic, or unknown intent, and by dose (therapeutic, supratherapeutic, or unknown). The expert panel also conducted a root cause analysis to document other factors that might have contributed to the child’s death.There were 7,983 cases of adverse events associated with CCMs identified by the Pediatric Cough and Cold Safety Surveillance System. Among these were 188 fatalities (2.3%). After review, 40 cases were judged to be related or potentially related to an index ingredient and included in the analysis. Overall, 24 cases (60%) occurred in children <2 years old and 29 (72.5%) in those <4 years old; 26 deaths (65%) occurred in boys. The CCM was administered by a parent or caregiver in 28 cases. All 3 cases in which the child self-administered the CCM involved a solid adult-formulation diphenhydramine product. Overall, 22 fatalities (55%) were from nontherapeutic use, 6 (15%) from therapeutic use, and in 12 cases therapeutic intent could not be determined. Dose was judged to be supratherapeutic in 8 cases (20%) and could not be determined in 32. At least 1 additional ingredient besides the index CCM was involved in 17 fatalities; the most common additional ingredients were opioids (N = 11). Among the 40 fatalities, 7 (17.5%) were related to use of a CCM to sedate a child, and 6 (15%) were from the use of a CCM to murder the child.The authors conclude that pediatric fatalities associated with CCMs primarily occur in younger children and after intentional nontherapeutic administration by a caregiver.Dr Alissa has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.Adverse drug events in children associated with CCM have been the center of discussion for more than a decade.1 Numerous articles have been written about the risk of CCM ingestions for therapeutic and nontherapeutic intent, in therapeutic and supratherapeutic doses.2 The consensus in these reports is that no fatality involves a therapeutic dose of CCM.2The misuse of over-the-counter medications including diphenhydramine has become a worldwide health concern.3 Palmer et al found that exposures to diphenhydramine-only products are the most common type of exposure that leads to adverse events associated with CCM in children.4 Despite international and national warnings, physicians frequently overprescribe and parents overuse CCM for upper respiratory tract infection in young children.5CCM were a major category of pharmaceuticals maliciously administered to children less than 2 years old in a retrospective database study conducted by researchers at the University of Colorado. Do caregivers administer a sedating agent simply as a break from the responsibilities of childcare?6The current study’s strength is the multiple national sources used to collect the data. Including specific index ingredients also is a strength of the study. The main limitation is the lack of information about the group of children who died due to the ingestion of an unknown dose of CCM.CCM remains dangerous for all children, especially those <2 years old. More restricted use is recommended.Physicians consider prescribing for children >12 months of age a sweet alternative to CCMs that is safe and efficacious: honey. (See AAP Grand Rounds. 2013;29[2]:14.)7