Cough and cold medications are risky for children

Dart RC, Paul IM, Bond GR, Winston DC, Manoguerra AS, Palmer RB, et al. Pediatric fatalities associated with over the counter (nonprescription) cough and cold medications. Ann Emerg Med 2009;53:411-7.

Question 

Among children who use over-the-counter (OTC) cough and cold medications, what is the risk of dying from these medications?

Design 

Case series developed from five different sources of information, including the medical literature, FDA databases, and manufacturers' reports.

Setting 

An independent panel of eight experts (pediatrics, pediatric critical care, pediatric toxicology, clinical toxicology, forensic toxicology, forensic pathology) used explicit definitions to assess the causal relationship between medication ingestion and death.

Participants 

Children under 12 years of age who died in which the report mentioned a cough and cold ingredient.

Outcomes 

Death among children associated with cough and cold medicine ingredient.

Main Results 

The experts found that of 189 cases, 118 were judged possibly, likely, or definitely related to a cough and cold ingredient. Of the latter, 103 involved a nonprescription drug and of these 88 involved an overdose. In 15, a dosage could not be determined. The authors identified that age younger than two years, use of the medication for sedation, use in a daycare setting, combining two or more medications with the same ingredient, failure to use a measuring device, product misidentification, and use of products intended for adults were associated with the fatalities. Finally, the review of the information showed that six of the children died after an attempt to sedate them, three were cases of abuse, and in 10 homicide was suspected.

Conclusions 

Pediatric death caused by nonprescription cough and cold medications are usually associated with an overdose in children less than 2 years old. The intent of caregivers appears to be therapeutic to relieve symptoms in some cases and non-therapeutic to induce sedation or to facilitate child maltreatment in other cases.

Commentary 

OTC cough and cold preparations have been known to result in very little clinical benefit and some adverse events. This paper by a group of inter-professionals, represent an extensive effort in combing the literature in order to identify fatalities associated with cough and cold medications. Beyond just sorting out case reports in the indexed literature, the authors review parents' and manufacturers' records. What was found in this study and was previously reported is that some of these pediatric deaths were associated with preventable errors in administration of OTCs. Efforts to eliminate administration of two drugs containing the same components, providing measuring devices to ensure correct dosage administration and clear differentiation between adult and pediatric regimens are some of the possible solution that can prevent future therapeutic errors. What is maybe most important to learn from these findings is that fatalities were associated with a non-therapeutic intent of parents and day care workers, and included intent to sedate the children, abuse, and even homicide. These findings must alert pediatricians and other medical care providers to enhance regulatory and educational efforts, in order to eliminate these deaths. Furthermore, the findings are likely only the tip of the iceberg, and the number of deaths reported is an underestimate of the true incidence, if one takes into account the millions of children receiving these preparations.