Use of Cold Medicine for Under 6-Year-Olds Prohibited
By Matthew Williams
18:07, September 29th 2007
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Use of Cold Medicine for Under 6-Year-Olds Prohibited

According to Food and Drug Administration safety specialists, the use of cough and cold medicine for kids under six-years-old should be banned.

The recommendation was made in a 356-page review on medicine and consumer safety, and represents a strong signal to the elimination actions of 800 popular U.S. medicines marketed in the United States under names like Toddler’s Dimetapp, Triaminic Infant and Little Colds. In a meeting to take place on October 18 and 19 experts will 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 review wrote that according to its belief and results in recent testing, the medicines are ineffective in young children and could moreover even 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 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, also released on Friday, that the F.D.A. 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.

 

 



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