FDA Panel Recommends Ban on Cold Medicines for Kids

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A ban already has the support of safety experts at the FDA, who published a 365-page review last month that showed decongestants and antihistamines have been linked with 123 pediatric deaths since 1969.

Many outside experts were also in favor of restricting children's access to cold remedies.

"The panel should recommend that the FDA carefully reevaluate their existing approval of cough and cold preparations being marketed to children under 6," said Dr. Michael Shannon, chief of the division of emergency medicine at Children's Hospital Boston, before the hearings began Thursday.

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"This recommendation is exactly what is needed to alert parents and policymakers about the erroneous labeling, marketing, and use of these products. Moreover, these medicines are ineffective and dangerous to young children," Bruce Lesley, president of the children's advocacy group First Focus, said in a statement released after the votes Friday.

The products covered in the debate include approximately 800 popular medicines sold in the United States under names such as Toddler's Dimetapp, Triaminic Infant and Little Colds. Experts estimate that Americans spend about $2 billion annually on these types of medications.

Last week, leading drug makers announced a voluntary withdrawal of oral cough and cold medicines marketed for use in infants.

That move affected only infant oral medicines, not those intended and labeled for use in children aged 2 and older, Shannon noted.

Shannon, who filed the original petition with the FDA in March and was slated to testify at the hearings, doesn't think that last week's recall by manufacturers goes far enough. It only affects children under 2 and not children between 2 and 5, who make up two-thirds of those taking the drugs, he noted.

"They made an effort, but it was nowhere near far enough," Shannon said.

In addition, these cold products simply don't work, according to Shannon. "There is no reason to give something that costs money, is ineffective, and has potential risks," he said.

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