Purpose: To assess the impact of a voluntary withdrawal of over-the-counter cough and cold medications (OTC CCMs) labeled for children under age 2 years on pediatric ingestions reported to the American Association of Poison Control Centers.
Methods: Trend analysis of OTC CCMs ingestions in children under the age 6 years resulting from therapeutic errors or unintentional poisonings for 27 months before (pre-) and 15 months after (post-) the October 2007 voluntary withdrawal was conducted. The rates and outcome severity were examined.
Results: The mean annual rate of therapeutic errors involving OTC CCMs post-withdrawal, in children less than 2-years of age, 45.2/100,000 (95%CI 30.7-66.6) was 54% of the rate pre-withdrawal, 83.8/100,000 (95%CI 67.6-104.0). The decrease was statistically significant p < 0.02. In this age group, there was no difference in the frequency of severe outcomes resulting from therapeutic errors post-withdrawal. There was no significant difference in unintentional poisoning rates post-withdrawal 82.1/100,000 (66.0-102.2) vs. pre-withdrawal 98.3/100,000 (84.4-114.3) (p < 0.21) in children less than 2-years of age. There were no significant reductions in rates of therapeutic errors and unintentional poisonings in children ages 2-5 years, who were not targeted by the withdrawal.
Conclusions: A significant decrease in annual rates of therapeutic errors in children under 2-years reported to Poison Centers followed the voluntary withdrawal of OTC CCMs for children under age 2-years. Concerns that withdrawal of pediatric medications would paradoxically increase poisonings from parents giving products intended for older age groups to young children are not supported.
2010 John Wiley & Sons, Ltd.