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On Friday, October 10'th 2007, experts commissioned by the FDA recommended that the Food and Drug Administration pull approval for all cold and cough medicines for children under 6, a move considered long overdue by many pediatricians and child safety experts. Many drug makers, anticipating the release of the study, had already made a move to preemptively withdraw all cold medicines aimed at children under two a week earlier.
The Facts & Findings:
1. Cold medicines marketed towards children are ineffective, and include ingredients known to be dangerous. The products have been responsible for numerous child deaths. The ingredients used for the medicines, the same ones found in adult medication for coughs and colds, do not work in kids under 12 and should not be used.
2. In two separate votes, panelists said the medicines shouldn't be used in children under two, or in children under six. Another vote to recommend against the use of such medicines for kids ages 6-11 failed, though the panel did agree that there is no evidence suggesting such medicines work for this age group either.
3. The recommendation applies to all cold and cough medicines with decongestants, expectorants, antihistamines, or antitussives, including many popular products such as Dimetapp, Pediacare, Robitussin, Triaminic, Little Colds, and versions of Tylenol designed for cold and coughs. Thirty-nine different drugs are used in pediatric cold and cough products.
4. FDA pediatrician Dr. Dianne Murphy stressed that parents must understand that cold remedies are only designed to suppress symptoms, and don't make colds go away any faster. Furthermore, she stated that parents shouldn't try to suppress those symptoms. Coughs are how the body clears the lungs, and low-grade fevers are a normal defense of the body which helps to fight infections.
5. Many of the active ingredients in such medicines are also used in different drugs, so using a cold medicine in combination with something else often leads to accidental overdose.
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