FDA Advisers Reject Cold Meds for Kids

Popular remedies don't work and aren't safe for for children under 6
By Kevin Spak,  Newser Staff
Posted Oct 19, 2007 5:17 PM CDT
Carleen Ho holds a bottle of Concentrated Tylenol Infants' Drops Plus Cold & Cough in front of her daughter, Rachel Ho, who is under two years old, at a home in Palo Alto, Calif., Thursday, Oct. 11, 2007....   (Associated Press)
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(Newser) – Over-the-counter cold medicines are dangerous for children under 6 and should not be used, a panel of health advisers reported to the FDA today. Many popular medicines, including Dimetapp, Triaminic, and Pediacare, have never been sufficiently tested on children under 12, the committee concluded. “The data that we have now is they don’t seem to work,” said one FDA expert.

The recommended ban includes medicines that contain decongestants, expectorants, antihistamines, and antitussives, the AP reports. The resolution is nonbinding, but the FDA usually follows the panel's recommendations. The ruling could lead to changes in the way cold medicines—which the industry says are used on kids nearly 4 billion times a year—are labeled, marketed, and used.