TABLE 2

ED Visits for ADEs Among Children Aged <2 Years Treated Before and After OTC Infant CCM Market Withdrawal: United States, January 1, 2004–December 31, 2011

Exposure TypeaEstimated Average Annual ED Visits Before Market WithdrawalEstimated Average Annual ED Visits After Market WithdrawalDifference in Proportions
No. of CCM RVNo. of All Medication RVProportion of CCM-RV Among All Medication RV, %No. of CCM RVNo. of All Medication RVProportion of CCM-RV Among All Medication RV, %%95% CI
Total213852 5434.1152963 5172.4−1.7−2.7 to –0.6
Supervised administrations103131 3183.354636 5131.5−1.8−2.9 to –0.6
Unsupervised ingestions110721 2265.298427 0053.6−1.6−3.4 to 0.3
  • Estimates from National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance, Centers for Disease Control and Prevention. CCMs include orally administered prescription or OTC products containing decongestants, antitussive agents, and/or expectorants alone or in combination with each other and/or with analgesics or antihistamines. Market withdrawal of OTC CCMs labeled for infants was announced in October 2007. The period before withdrawal refers to the period beginning January 1, 2004, and ending September 30, 2007. The period after withdrawal refers to the period beginning October 1, 2007, and ending December 31, 2011. RV, related visits.

  • a Exposure type was classified as supervised administrations when caregivers gave medications to children. Exposure type was classified as unsupervised ingestions when children accessed medications without adult permission or oversight.