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FDA Panel Recommends Ban on Cold Medicines for Kids
Date:10/19/2007

Over-the-counter drugs are unsafe for children under 6, advisers say.,,

FRIDAY, Oct. 19 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel on Friday recommended a ban on over-the-counter cough and cold medicines for children younger than 6.

Citing a number of studies that showed the remedies were no better than a placebo, the outside experts also recommended the drugs be tested on children to see if they are effective.

"Even for adults, evidence that the drugs work is modest at best," said Dr. Mary E. Tinetti, chairwoman of the FDA panel and a professor at Yale University School of Medicine, according to The New York Times.

In two separate votes at the end of two days of hearings on the safety of the drugs for children, the advisers said the medicines shouldn't be used in children younger than 2 or in those younger than 6. A third vote, to recommend against use in children aged 6 to 11, failed, the Associated Press reported. An earlier vote recommended the use of the medications needs to be studied specifically in children.

The recommendations apply to medicines containing one or more of the following ingredients: decongestants, expectorants, antihistamines and antitussives, the AP reported.

The FDA does not have to follow its advisory panels' recommendations, but usually does.

A ban already has the support of safety experts at the FDA, who published a 365-page review last month that showed decongestants and antihistamines have been linked with 123 pediatric deaths since 1969.

Many outside experts were also in favor of restricting children's access to cold remedies as the hearing began Thursday.

"The panel should recommend that the FDA carefully reevaluate their existing approval of cough and cold preparations being marketed to children under 6," said Dr. Michael Shannon, chief of the Division of Emergency Medicine at Child
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