TABLE 3.
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 Typea |
Estimated Average Annual ED Visits Before Labeling Revision Announcement |
Estimated Average Annual ED Visits After Labeling Revision Announcement |
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 | |
| Children aged 2–3 | ||||||||
| Total | 4092 | 43 100 | 9.5 | 3480 | 53 447 | 6.5 | −3.0 | −5.4 to –0.6 |
| Supervised administrations | 577 | 10 618 | 5.4 | 390 | 15 634 | 2.5 | −2.9 | −5.4 to –0.5 |
| Unsupervised ingestions | 3515 | 32 482 | 10.8 | 3090 | 37 813 | 8.2 | −2.6 | −5.3 to -0.01 |
| Children aged 4–5 | ||||||||
| Total | 852 | 15 128 | 5.6 | 1453 | 22 338 | 6.5 | 0.9 | −1.7 to 3.4 |
| Supervised administrations | 485 | 10 354 | 4.7 | 762 | 16 059 | 4.7 | 0.1 | −2.8 to 2.9 |
| Unsupervised ingestions | 366 | 4774 | 7.7 | 691 | 6279 | 11.0 | 3.3 | −1.9 to 8.6 |
| Children aged 6–11 | ||||||||
| Total | 875 | 22 152 | 3.9 | 917 | 30 410 | 3.0 | −0.9 | −2.5 to 0.6 |
| Supervised administrations | 765 | 19 198 | 4.0 | 758 | 27 095 | 2.8 | −1.2 | −2.8 to 0.4 |
| Unsupervised ingestions | — | 2954 | — | — | 3315 | — | — | — |
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.
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.