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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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