Aurora, CO—
Even though some infant products were withdrawn and labels were changed for safety reasons in 2007 and 2008, most of the pediatric deaths associated with use of OTC cough and cold medications (CCMs) included in a multidata-source national surveillance system from 2008 to 2016 occurred in children younger than age 2 years, according to a new report.

The article in Pediatrics advises that the index ingredient usually involved was diphenhydramine, and that it often was administered with nontherapeutic intent.

Researchers from Children’s Hospital Colorado and the University of Colorado Anschutz Medical Campus and colleagues used the Pediatric Cough and Cold Safety Surveillance system to identify fatalities in children younger than age 12 years that occurred between 2008 and 2016 and were associated with oral exposure to one or more CCMs. All cases were reviewed by an expert panel to determine the causal relationship between the exposure and death, if the intent of exposure was therapeutic, and if the dose was supratherapeutic.

Results indicate that, of the 180 eligible fatalities included from the study period, 40 were judged by the expert panel to be either related or potentially related to the CCM. Of those, 60% occurred in children younger than age 2 years and 55% involved nontherapeutic intent; diphenhydramine was involved 70% of the time. In six cases (15.0%) the CCM was administered to murder the child, according to the authors, while in another seven cases (17.5%) the child died after a caregiver’s intentional use of the CCM for sedation.

“Pediatric fatalities associated with CCMs occurred primarily in young children after deliberate medication administration with nontherapeutic intent by a caregiver,” the authors conclude.

The authors urge pharmacists and other healthcare providers to “educate parents and caregivers on avoidance of CCMs, particularly diphenhydramine in children <4 years old as part of routine guidance and during encounters for respiratory complaints.”

The study raises alarms about how many of the fatalities occurred because of suspected child maltreatment. “More research is needed to understand the intersection of child maltreatment and pharmaceutical poisoning so that the medical community and child welfare advocates can develop targeted screening and prevention programs,” the researchers emphasize.

Background information in the report points out that OTC CCM use in young children is extremely common, with nearly half of parents with children younger than 4 years of age reporting having administered a CCM when their child last had a cold.

In 2007, after the FDA reviewed the safety and efficacy of CCMs in children, drug manufacturers voluntarily withdrew “infant” CCM products from the market. The next year, the FDA released a Public Health Advisory recommending that these products not be used in children younger than age 2 years, and manufacturers voluntarily changed CCM labeling to state “do not use” in children younger than age 4 years. Labeling also specifically instructed that caregivers not use CCMs containing certain antihistamines to sedate or make a child sleepy.

Overall, the study adds that pediatric fatalities associated with CCMs are rare, accounting for fewer than 3% of all reported serious adverse event cases detected by a national multidata-source surveillance system over a 9-year period. “We found that in most cases with identifiable characteristics, the child was <2 years old and had been deliberately given a CCM by a caregiver, the majority of which involved nontherapeutic intent. The most common ingredients involved were diphenhydramine, chlorpheniramine, and dextromethorphan, and in several fatalities, at least 1 nonindex ingredient contributed to the child’s death. There were no fatalities associated with a known therapeutic dose,” the authors write.

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