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FDA Panel Weighs Ban on Kids' Cold Medicines
Date:10/18/2007

There's no proof they help children under 6, and they may do harm, critics say

THURSDAY, Oct. 18 (HealthDay News) -- Beginning Thursday, a panel of experts at the U.S. Food and Drug Administration will consider banning the sale of over-the-counter cough and cold medicines for young children.

Such a ban already has the support of safety experts at the FDA, who published a 365-page review on the issue in late September. Any recommendation from the advisory panel would apply to decongestant use in children under 2, and antihistamines in those younger than 6. While the FDA does not have to follow a panel's recommendation, it usually does.

According to the FDA safety review, decongestants and antihistamines have been linked with 123 pediatric deaths since 1969.

Many outside experts are also in favor of restricting children's access to cold remedies.

"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 Children's Hospital Boston. "Our hope is that they will agree that it is not appropriate to market these products to children."

The products covered in the debate include approximately 800 popular medicines sold in the United States under names such as Toddler's Dimetapp, Triaminic Infant and Little Colds. Experts estimate that Americans spend about $2 billion annually on these types of medications.

Last Thursday, leading drug makers announced a voluntary withdrawal of oral cough and cold medicines marketed for use in infants.

That move affected only infant oral medicines, not those intended and labeled for use in children age 2 and older, Shannon noted. And it comes as U.S. regulators review the products' safety.

Shannon, who filed the original petition with the FDA in March and is testifying at the he
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