CHPA issues warning regarding overreaction in FDA assessment of pediatric cough-cold medicines

WASHINGTON The Consumer Healthcare Products Association on Friday issued a caution regarding the recommendations issued last week by the Food and Drug Administration’s nonprescription drugs advisory committee and pediatric advisory committee on the use of cough and cold medicines in children.

“For decades, parents and other caregivers have relied upon and trusted pediatric cough and cold medicines to relieve symptoms of the common cold in children and provide real comfort to children with runny noses, congestion and coughs,” stated Linda Suydam, CHPA president.

“We believe that some of today’s advisory committee recommendations support and confirm the risk-management efforts we have proposed. However, other recommendations–notably the split vote to make single active ingredients no longer available for use in children under six years old–if adopted by FDA, would unduly limit parents’ access to medicines that work and are safe when taken as directed,” she said. “The committee’s split majority vote on this matter clearly did not reflect a consensus of opinion, and we hope the FDA will weigh this recommendation with great caution. Adoption of this recommendation would leave parents with no over-the-counter medicinal relief when their children are suffering from cold symptoms.”

The issue over the inherent safety of these medicines as proven anecdotally by their decades of continued use in millions of children was raised more than once during the meeting of the two FDA advisory committees.

The appropriateness of extrapolating efficacy studies of these medicines conducted in adult populations onto children was also debated. “[Friday], the advisory committee decided that there was insufficient evidence in pediatric populations to support efficacy. This is an issue we will address with FDA. We are already planning pharmacokinetic studies in children, which are the first step toward confirming correct dosing, and we will work with FDA to design appropriate pediatric clinical efficacy studies,” Suydam said.

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