Impact of the voluntary withdrawal of over-the-counter cough and cold medications on pediatric ingestions reported to poison centers.
OBJECTIVE
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.
Maryland Poison Center, University of Maryland School of Pharmacy, Baltimore, MD, USA. wkleinsc@rx.umaryland.edu
Wendy
W
Klein-Schwartz
John David
JD
Sorkin
Suzanne
S
Doyon
D002675:Child, Preschool; D003139:Common Cold / Q000150:complications* / Q000188:drug therapy*; D003371:Cough / Q000150:complications* / Q000188:drug therapy*; D003915:Dextromethorphan / Q000506:poisoning / Q000627:therapeutic use; D004435:Eating; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D004366:Nonprescription Drugs / Q000009:adverse effects / Q000506:poisoning / Q000627:therapeutic use; D010290:Parents; D011039:Poison Control Centers; D054199:Pseudoephedrine / Q000009:adverse effects / Q000506:poisoning / Q000627:therapeutic use; D056737:Safety-Based Drug Withdrawals
D004366:Nonprescription Drugs; D003915:Dextromethorphan; D054199:Pseudoephedrine