Published online January 28, 2008
PEDIATRICS (doi:10.1542/peds.2007-3638)
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ARTICLE

Adverse Events Attributable to Cough and Cold Medications in Children

Melissa K. Schaefer, MDa,b, Nadine Shehab, PharmDa, Adam L. Cohen, MD, MPHc and Daniel S. Budnitz, MD, MPHa

a Division of Healthcare Quality Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases, Coordinating Center for Infectious Diseases
b Epidemic Intelligence Service, Office of Workforce and Career Development
c Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia

BACKGROUND. Adverse drug events in children attributable to cough and cold medications have been identified as a public health issue with clinical and policy implications. Nationally representative morbidity data could be useful for targeting age-appropriate safety interventions.

OBJECTIVE. To describe emergency department visits for adverse drug events attributable to cough and cold medications in children.

METHODS. Emergency department visits for adverse drug events attributable to cough and cold medications among children aged <12 years were identified from a nationally representative stratified probability sample of 63 US emergency departments from January 1, 2004, through December 31, 2005.

RESULTS. Annually, an estimated 7091 patients aged <12 years were treated in emergency departments for adverse drug events attributable to cough and cold medications, accounting for 5.7% of emergency department visits for all medications in this age group. Most visits were for children aged 2 to 5 years (64%). Unsupervised ingestions accounted for 66% of estimated emergency department visits, which was significantly higher than unsupervised ingestions of other medications (47%), and most of these ingestions involved children aged 2 to 5 years (77%). Most children did not require admission or extended observation (93%).

CONCLUSIONS. Timely national surveillance data can help target education, enforcement, and engineering strategies for reducing adverse events attributable to cough and cold medications among children. Engineering innovations could be particularly helpful in addressing unsupervised ingestions, which is the most frequent cause of adverse events. These innovations could be applicable to other children's medications.

Key Words: adverse events • drug safety

Abbreviations: OTC—over-the-counter • FDA—Food and Drug Administration • ED—emergency department • ADE—adverse drug event • NEISS-CADES—National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance • CI—confidence interval

Accepted Dec 11, 2007.