National Survey Shows 1 In 10 Children Use Cough/Cold OTCs Each Week

A long-term study underscores possible risks from OTC pediatric cough/cold products and emphasizes the significance of FDA's ongoing review of the medicines' safety and efficacy for 2- to 11-year-old children.

The Boston University study published online Aug. 4 in the journal Pediatrics says regulatory changes FDA is considering and efforts aimed at educating caregivers about the safe use of OTC cough/cold products "may be needed to reduce inappropriate exposure to these medications and thereby minimize risks to children."

Further, the prevalent use of OTC cough/cold drugs among U.S. children "suggests that efforts on educating the public about safe use" of the products "should be broadly targeted," write researchers led by Louis Vernacchio, an assistant professor of epidemiology and pediatrics at Boston University School of Medicine.

FDA has yet to release a working group's report on whether young children should use OTC cough/cold products. The working group also will review possible changes to the pediatric cough/cold monograph (¹ (Also see "FDA Working Group Considering Changes To OTC Cough/Cold Monograph" - Pink Sheet, 21 Jan, 2008.), p. 3).

Agency officials initially said they expected to issue a decision by this spring.

The Pediatrics study, based on data from a national random-digit-dial telephone survey conducted from 1999 to 2006 by the Slone Epidemiology Center at BU, found one in 10 U.S. children use at least one OTC cough/cold product in a given week. The majority of the children are under the age of 5.

The study finds exposure to antitussives, decongestants and first-generation antihistamines was highest among 2- to 5-year-olds (7 percent, 9.9 percent and 10.1 percent, respectively), followed by children who were younger than 2 (5.9 percent, 9.4 percent and 7.6 percent).

The "particularly high" use of OTC cough/cold products by young children raises "a potential safety concern because nearly all published reports of [cough/cold product]-associated serious adverse events and deaths have involved very young children," Vernacchio and his colleagues say.

The authors point to a Centers for Disease Control and Prevention study that links 1,500 emergency room visits in 2004 through 2005 to cough/cold products.

Another study, by the American Association of Poison Control Centers, reveals that 75 percent of all fatal adverse events related to accidental ingestion or overdose of cough/cold products occur in children under 2 years old ("² (Also see "Child-Resistant Packaging In The Works For More OTC Cold Products – CHPA" - Pink Sheet, 4 Feb, 2008.), p. 8).

The Slone researchers acknowledge inadvertent overdose is one of the greatest risks for very young children "for whom dosing recommendations are largely extrapolated from adults and the risk for adverse events is greatest," according to the study.

Additionally, use of cough/cold products by young children is "fraught with the potential for dosing errors" because "concentrations and dosages ... are not standardized across products, dosage delivery devices differ from product to product and products with different ingredients can have similar names."

FDA has proposed a pilot program to evaluate the safety of proprietary drug names, including OTCs (³ (Also see "Umbrella Brands Help Identify “Known And Trusted” Products – CHPA" - Pink Sheet, 21 Jul, 2008.), p. 11).

Leading manufacturers of OTC cough/cold products voluntarily withdrew oral cough/cold products for infants last fall "out of concern that their potential misuse could lead to possible overdose among very young children," a Consumer Healthcare Products Association spokeswoman said.

The study authors acknowledged "the prevalence and patterns of pediatric" cough/cold product use "are likely to change substantially" because of the industry's voluntary withdrawal of infant cough/cold products and an FDA advisory panel's recommendation that children under 2 not use the products (⁴ (Also see "FDA Panel Narrowly Votes Against Cough/Cold Drugs For Children Up To Age 6" - Pink Sheet, 22 Oct, 2007.), p. 3).

The CHPA spokeswoman added that the study underscores "the need to educate all consumers on the importance of always following the directions, using the correct dosing device, keeping medicines safe and consulting their doctor with any questions."

She also noted CHPA kicked off an educational advertising campaign in November 2007 to inform parents about the appropriate use of OTC cough/cold products. The trade group also launched an educational Web site as a reference for consumers (⁵ (Also see "CHPA Rolls Out Pediatric Cough/Cold Education Campaign" - Pink Sheet, 5 Nov, 2007.), p. 9).

- Elizabeth Crawford ([email protected])