FDA to recommend against use of cough-cold for children under two

WASHINGTON The Food and Drug Administration is expected to announce Thursday that cough and cold medicines are not appropriate for use in children under the age of two. Medicines marketed to this age group carried the warning “consult your physician” for children under age two up until the fall of last year, when industry voluntarily pulled all product marketed for use in toddlers off the market.

The move was heralded by the Consumer Healthcare Products Association. “Safety has always been and continues to be our top priority,” stated Linda Suydam, CHPA president. “Last fall, the leading makers of OTC, oral cough and cold medicines for infants voluntarily withdrew these medicines out of concern that their potential misuse could lead to possible overdose among very young children. While CHPA and its member companies believe that the large majority of parents and caregivers know how to safely and appropriately administer these medicines, and that they are safe when taken as directed, we took this voluntary action recognizing that infants are especially vulnerable to accidental misuse.”

Suydam noted that the CHPA has already kicked off a new educational campaign for parents and caregivers of small children.

The decision follows an FDA advisory committee meeting held in October, which addressed safety and efficacy of cough/cold products in children. A decision on whether or not cough-cold medicines are appropriate for children older than two is expected in the spring.