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By GARDINER HARRIS Published: September 29, 2007
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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.
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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 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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There are thousands of such unapproved drugs on the market. Indeed, an estimated 2 percent of all prescriptions are written for unapproved products. Most have been around for decades, and the F.D.A. is gradually forcing their makers to either get official approval or stop selling them.
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Parents need to read. I NEVER gave my kids medication unless it was prescribed. A cough is a defensive reaction to congestion. A fever is the bodies sign that it is fighting infection. I have always been one of those nuts who believes that you should never take medication unless it was absolutely necessary and then only when supervised by a doctor. And now over the last decade or so I've become suspicious of them as well. Not that I think I'm smarter than they are, but because they are so damn quick to handing out medications from the drug rep that waiting outside to see him/her at the same time I was.
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