Pediatric fatalities from non-prescription cough and cold medications are rare, but may indicate the possibility of child abuse. The largest study of child death associated with cough and cold products is published in the Annals of Emergency Medicine ("Pediatric Fatalities Associated With Over-The-Counter (Nonprescription) Cough and Cold Medications").Researchers studied several sources for deaths in children associated with cough and cold products between 1966 and 2007 (the year that the U.S. Food and Drug Administration (FDA) recommended a prohibition against the use of such drugs in children under the age of six). They found 103 deaths related to nonprescription cough and cold medicines.
"Although much attention has been paid to accidental deaths in children from cough and cold products, we found that these deaths followed overdose of the cough and cold medicine" said Richard Dart, MD, PhD, Director of the Rocky Mountain Poison and Drug Center of the Denver Health and Hospital Authority in Denver. "It was disturbing to find cases where the adult was attempting to sedate a child and even more disturbing to find many cases of apparent child abuse."
The drugs most prevalent in the fatalities were pseudoephedrine, diphenhydramine and dextromethorphan.
The researchers found two types of cases involved in the deaths: a caregiver was trying to treat a child's cough and cold symptoms, but inadvertently administered an overdose of the medication, or the caregiver intentionally administered an overdose of cough and cold medicine to the child to harm the child or to control their behavior.
The most vulnerable population appears to be children less than two years of age. These patients accounted for 75 percent of the deaths. The use of these drugs in this population has recently been discouraged by the manufacturers of these drugs and the FDA through product label changes and FDA committee meetings and a public advisory notice.
"The small size of young children makes inadvertent overdose easier,” said Dr. Dart. “Furthermore, it's harder for these children to communicate toxic effects of the drugs when too much is given.”
Approximately four million children under the age of 12 are treated with over-the-counter cough and cold products each week in the United States. Despite the FDA recommendation that such medicines not be used in children under the age of six, recent polls show that 20 percent of parents with children under the age of two and 30 percent of parents with children ages two to six plan to use them for their children.
"There are several steps that could be taken in the interest of public health," said Dr. Dart. "First, providers and medical examiners must be aware that cough and cold medicines are sometimes used to intentionally harm children. Careful investigation of any case that could involve cough and cold medicines is prudent. Second, labels and packaging can be modified to make unintended overdose much less likely. Third education of caregivers is essential. It is important to understand that many of the death involved caregivers other than parents, such as day care providers."