An FDA advisory panel decided in split votes Oct. 19 to recommend immediately that all OTC cough/cold medicines should not be used for 2-to 5-year-old children but are safe for 6- to 12-year-olds.

At a joint meeting in Silver Spring, Md., members of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee voted unanimously to recommend "no use" of OTC antitussive, expectorant, nasal decongestant, antihistamine and combination cough/cold products for children under 2.

However, the committees' votes were split on recommendations for older children after several members warned that without products labeled for use by children, parents and other caregivers will administer adult medicines.

"Do you really want to be responsible for the outcry when these things become unavailable?" said Richard A. Neill, a physician and a professor at the University of Pennsylvania School of Medicine.

The committees voted 13-9 to recommend against the use of the products for children ages 2 to 5, but they voted down, 15-7, making the same recommendation for 6- to 12-year-olds.

The Consumer Healthcare Products Association suggests the split over the under 6 population weakens the recommendation.

The group said "some of today's advisory committee recommendations support and confirm the risk-management efforts we have proposed," in a same-day statement. CHPA members this month voluntarily withdrew from the market cough/cold products marketed for children under 2 (¹ Also see "Infant Cold Products Pulled; Waxman Looks For More OTC Risks" - Pink Sheet, 15 October, 2007., p. 6).

The committees' split votes over the under 6 population "clearly did not reflect a consensus of opinion, and we hope the FDA will weigh this recommendation with great caution," the group said. "If adopted by FDA," the recommendation "would unduly limit parents' access to medicines that work and are safe when taken as directed."

Generally, the committees said available data does not demonstrate the efficacy of cough/cold products for children. "The overwhelming sentiment is for [children] under 12 there is no efficacy data," said NDAC Chairwoman Mary E. Tinetti, a physician and a Yale School of Medicine professor.

In a briefing following the meeting, FDA Office of New Drugs Director John Jenkins said the committees made clear their efficacy concerns. "The message from the panel is they haven't seen evidence from adequately controlled studies that these products work in children. That's scientifically different from a statement that they don't work in children."

The panel also recommended the extrapolation of data from adult studies should not be used to show efficacy of OTC cough/cold products for children under 12.

Panel members said more accurate data can be provided from studies that directly measure the efficacy of nonprescription cough/cold products in children. "The studies available do not demonstrate efficacy," said PAC member Robert S. Daum, a physician and a professor of pediatrics at the University of Chicago Medical Center.

Daum added that available studies on the efficacy of cough/cold products in children "have limitations, they are few in number, they are underpowered."

However, PAC member Avita Cnaan, chief of the Children's Hospital of Philadelphia Division of Biostatistics and Epidemiology, said the quality and quantity of studies available should not influence whether the committees endorse extrapolating data to show a drug's efficacy in use by children.

"The reason they didn't show benefit maybe is because there is no benefit. We just don't know," Cnaan said.

CHPA representatives made a presentation at the meeting to reiterate their position that pediatric cough/cold drugs are effective and safe when used appropriately. They also discussed plans for pharmacokinetic studies to confirm or refine pediatric cough/cold ingredient dosing (² Also see "CHPA Plans Education Campaign To Reduce Children’s Cold Product Risks" - Pink Sheet, 1 October, 2007., p. 4).

The joint meeting Oct. 18 and 19 was scheduled to discuss concerns raised in a citizen petition submitted in March by 16 pediatricians and health care professionals (³ Also see "FDA Floats Eliminating Multi-Ingredient Pediatric Cold Products" - Pink Sheet, 1 October, 2007., p. 3).

- Malcolm Spicer (m.spicer@elsevier.com) and Katie Stevenson (k.stevenson@elsevier.com)

FDA Panel Narrowly Votes Against Cough/Cold Drugs For Children Up To Age 6

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