Stop giving drugs to infants is the thrust of recommendations made in the US by safety experts for the Food and Drug Administration who urged an outright ban on over-the-counter, multisymptom cough and cold medicines for children under 6. This recommendation is underpinned by the recognition that warnings about their use on infants just do not influence behaviour in our society which is hooked on convenient solutions. Parents will opt for the numbing dose of drugged syrup for their 1 year old over diet, rest and nurturing care; and the dosages are not insignificant and are repeated. 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.
The expert 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 US under names like Toddler’s Dimetapp, Triaminic Infant and Little Colds. The 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 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.
The Consumer Healthcare Products Association, an industry trade group that has consistently defended the safety of pediatric cough and cold medicines, recommended in its own 156-page safety review, released on the same day, that the FDA consider mandatory warning labels saying that they should not be used in children younger than 2. Many cough and cold medicines now advise parents to “consult a physician” before use in such children. But we know these warnings don’t work and their recommendation is self-serving designed to mollify regulators while maintaining sales of their dope.
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