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Ban Urged On Tots' Cold Drugs

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By GARDINER HARRIS, The New York Times

Published: September 30, 2007

WASHINGTON - Safety experts for the Food and Drug Administration urged the agency on Friday to consider an outright ban on over-the-counter, multi-symptom cough and cold medicines for children younger than 6.

The recommendation, in a 356-page safety review, is the clearest signal yet the agency may take strong action against about 800 popular medicines marketed in the United States under names such as Toddler's Dimetapp, Triaminic Infant and Little Colds.

The next step in the process will be 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 FDA's experts suggested all 'infant' cough and cold formulations be removed from the market, and the droppers, cups and syringes included with products for children be standardized to reduce the risks of confusion and overdose.

The reviewers wrote there is little evidence these medicines are effective in young children, and there are increasing fears 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. It added that because adverse drug reactions are reported voluntarily and fitfully, the numbers were likely to significantly understate the medicines' toll.

The Consumer Healthcare Products Association, an industry trade group that has defended the safety of pediatric cough and cold medicines, recommended in its own 156-page safety review released Friday that the FDA consider mandatory warning labels saying that they should not be used by children younger than 2.

Many cough and cold medicines now advise parents to 'consult a physician' before use by such children.

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