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Deaths from OTC Cough and Cold Medicine

January 4, 2022

Written by Denrick Cooper

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Cough and cold medications (CCM) have off-label usage as sedatives and, unfortunately, for child mistreatment. Pediatric populations, especially those < 2 years of age, are most susceptible to CCM related deaths.

Why does this matter?
A significant number of parents use CCM at home. Off-label usage of these medications can be detrimental to children, especially those under 2 years of age. Although uncommon, CCM is a cause of child maltreatment in younger age groups.

Not Mary Poppins’ spoonful of sugar
In 2008, The FDA disseminated a Public Health Advisory to reduce the amount of CCM related deaths in the pediatric population. In response, CCM manufacturers rewrote medication labels instructing to not use in children < 4 years old. This study is a retrospective descriptive analysis of CCM related deaths in children <12 years old between 2008-2016, after the labeling was changed.

A panel of experts found 40 fatal cases associated with CCM in the Pediatric Cough and Cold Safety Surveillance System. Most were male, <2 years old, and the oral agent was administered by the parent.  A majority of cases were for off-label usage (i.e. sedation), accidental exploratory ingestion or malicious usage. The most common ingredient was diphenhydramine.

This study has a small number of participants, so it is difficult to make sweeping generalizations. Furthermore, it is difficult to prove intent of CCM related deaths unless the parent outright admits it. We may be looking at underreported numbers, and the actual number of children affected is larger than this study is finding.

My own practice is to continue to endorse alternatives to CCM for URI symptoms and give clear prescriptions with weight-based instructions for any medications used. At the same time, we must be aware that child mistreatment can take the form of intentional medication overdose in our young pediatric population.

Pediatric Fatalities Associated With Over-the-Counter Cough and Cold Medications. Pediatrics. 2021 Nov;148(5):e2020049536. doi: 10.1542/peds.2020-049536. Epub 2021 Oct 4.

What are your thoughts?