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. Author manuscript; available in PMC: 2015 Dec 30.
Published in final edited form as: Pediatrics. 2013 Nov 11;132(6):1047–1054. doi: 10.1542/peds.2013-2236

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 Typea Estimated Average Annual ED Visits Before
Market Withdrawal
Estimated Average Annual ED Visits After Market
Withdrawal
Difference in
Proportions



No. of CCM RV No. of All
Medication RV
Proportion of
CCM-RV Among All
Medication RV, %
No. of CCM RV No. of All
Medication RV
Proportion of
CCM-RV Among All
Medication RV, %
% 95% CI
Total 2138 52 543 4.1 1529 63 517 2.4 −1.7 −2.7 to –0.6
Supervised administrations 1031 31 318 3.3 546 36 513 1.5 −1.8 −2.9 to –0.6
Unsupervised ingestions 1107 21 226 5.2 984 27 005 3.6 −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.