WASHINGTON, Sept. 28 — Safety experts for the Food and Drug Administration urged the agency on Friday to consider an outright ban on over-the-counter, multisymptom cough and cold medicines for children under 6.
The recommendation, in a 356-page safety review, is the strongest signal yet that the agency may take strong action against the roughly 800 popular medicines marketed in the United States under names like Toddler’s Dimetapp, Triaminic Infant and Little Colds.
The next step in the process is a meeting of outside experts on Oct. 18 and 19 to examine the medicines’ safety and offer recommendations to the agency.
In the new safety review, the agency’s experts suggested that all “infant” cough and cold formulations be removed from the market, and that the droppers, cups and syringes included with products for children be standardized to reduce the risks of confusion and overdose.
The reviewers wrote that there is little evidence that these medicines are effective in young children, and there are increasing fears that they may be dangerous. From 1969 to 2006, at least 54 children died after taking decongestants, and 69 died after taking antihistamines, the report said. And it added that since adverse drug reactions are reported voluntarily and fitfully, the numbers were likely to significantly understate the medicines’ true toll.
Read the whole article at the New York Times.
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