Commentary

• poisonings
• cough medications
• over-the-counter

Prior to 2007 as many as 1 in 10 children in the United States received OTC cough and cold medications each week. However, OTC cough and cold medications have not been shown to be effective in children,¹ and in young children the potential for harm is clear.² This discordance resulted in several changes to the labeling and new recommendations for OTC cough and cold medications in children. The key changes occurred between the 2 time periods examined in the current study and included a voluntary withdrawal by manufacturers of products directed at children <2 years of age (2007), guidelines by the FDA recommending against their use in children <2 years of age (2008), and a subsequent voluntary label change by manufacturers noting “do not use” in children <4 years of age (2008). In addition, the American Academy of Pediatrics supported the position that OTC cough and cold medications are not effective for children <6 years of age.³

A limitation to the current study is that it does not address trends in the overall use of OTC cough and cold medications in children, but instead only self-reported poisonings. A recent survey of parents found that two thirds were unaware of the FDA guidelines on OTC cough and cold medications in children <2 years of age.⁴ What are parents using as a guide for dosing since no information for children <4 years of age is available on the label? Additionally, direct causation of the decline in poisonings by OTC cough and cold medications cannot be established. Nonetheless, examination of medication misuse is informative. The temporal pattern of the large reduction of poisonings from OTC cough and cold medications in a national reporting system is highly suggestive of the impact that concerted efforts by the FDA, industry, and professional organizations had on improving the safety of medication use in children. Additionally, this study refutes concerns that OTC cough and cold medication poisonings would increase as parents turn to “off-label” use of formulations designed for older children and adults.

Continued guidance and education by pediatricians on the appropriate use (or nonuse) of OTC cough and cold medications in children, therefore, continues to be most important. Recent clinical studies supporting the use of honey for cough in children >1 year of age provide pediatricians a viable therapeutic alternative (see AAP Grand Rounds, March 2008;19[3]:28⁵ and AAP Grand Rounds, February 2013;29[2]:14⁶).