TABLE 1

Numbers of Cases and National Estimates of AEs from CCMs Among Children <12 Years of Age Treated in EDs Before and After Voluntary Withdrawal of OTC Infant CCMs, According to Case Characteristics: United States, July 22, 2006 to December 31, 2008

Case CharacteristicsED Visits Before Voluntary WithdrawalED Visits After Voluntary Withdrawal
Cases, nNational Estimate, n (% [95% CI])Cases, nNational Estimate, n (% [95% CI])
Patient age
    <2 y542790 (28.7 [21.0–36.3])361248 (13.3 [5.8–20.7])
    2–5 y1225928 (60.9 [52.1–69.8])1557154 (76.0 [67.7–84.3])
    6–11 y211009 (10.4 [4.7–16.1])231006a (10.7 [4.3–17.1])
Patient gender
    Female984755 (48.9 [39.5–58.3])944076 (43.3 [33.1–53.6])
    Male994972 (51.1 [41.7–60.5])1205332 (56.7 [46.4–66.9])
Type of ingestionb
    Unsupervised ingestion1366603 (67.9 [58.0–77.8])1476150 (65.4 [57.4–73.3])
    Supervised administration without documented medication error472685 (27.6 [18.4–36.9])482323 (24.7 [16.6–32.8])
    Supervised administration with documented medication error1419
ED treatment and disposition
    Gastric decontamination442180 (22.4 [14.6–30.3])351623 (17.3 [8.7–25.8])
    Treated and released or left against medical advice1648754 (90.0 [80.3–99.7])1708606 (91.5 [84.9–98.1])
Total19797272149408
  • Case counts and estimates were from the 2006–2008 NEISS-CADES project, Centers for Disease Control and Prevention. CCMs refer to orally administered prescription or OTC drug products that contain decongestant, antihistamine, antitussive, and/or expectorant combinations, as well as single-ingredient decongestants and antitussive agents/expectorants. Voluntary market withdrawal of OTC CCMs labeled for infants was announced on October 11, 2007. The period before withdrawal refers to the 14-month period beginning July 22, 2006, and ending October 11, 2007; the period after withdrawal refers to the 14-month period beginning October 12, 2007, and ending December 31, 2008. Estimates based on <20 cases are not shown (—).

  • a Estimate with coefficient of variation of 32.9.

  • b Unsupervised ingestion refers to cases in which children accessed the medication without adult permission or oversight. Supervised administration refers to cases in which the medication was administered by a caregiver. Medication errors include errors made during the prescribing, dispensing, or administration of the medication, as documented in the ED record.