ED Visits for ADEs Among Children Aged 2 to 11 Years Treated Before and After OTC Infant CCM Labeling Revision Announcement: United States, January 1, 2004–December 31, 2011

Age Group (y) and Exposure TypeaEstimated Average Annual ED Visits Before Labeling Revision AnnouncementEstimated Average Annual ED Visits After Labeling Revision AnnouncementDifference 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
Children aged 2–3
 Total409243 1009.5348053 4476.5−3.0−5.4 to –0.6
 Supervised administrations57710 6185.439015 6342.5−2.9−5.4 to –0.5
 Unsupervised ingestions351532 48210.8309037 8138.2−2.6−5.3 to -0.01
Children aged 4–5
 Total85215 1285.6145322 3386.50.9−1.7 to 3.4
 Supervised administrations48510 3544.776216 0594.70.1−2.8 to 2.9
 Unsupervised ingestions36647747.7691627911.03.3−1.9 to 8.6
Children aged 6–11
 Total87522 1523.991730 4103.0−0.9−2.5 to 0.6
 Supervised administrations76519 1984.075827 0952.8−1.2−2.8 to 0.4
 Unsupervised ingestions29543315
  • 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. OTC CCM labeling revision was announced in October 2008. The period before withdrawal refers to the period beginning January 1, 2004, and ending September 30, 2008. The period after withdrawal refers to the period beginning October 1, 2008, and ending December 31, 2011. Estimates based on <20 cases are not shown. 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.