Don't take your medicine

October 18, 2007

A special advisory committee of the federal Food and Drug Administration meets today and tomorrow to discuss whether over-the-counter pediatric cough and cold medicines are safe and effective for young children. The FDA has already recommended that common cough and cold medicines should not be given to infants and toddlers and that children under age 6 should not be given antihistamines.

Now the agency should go further, following the advice of a group of prominent Baltimore pediatricians, and insist that no cold medicines be given to any child under 6.

Many manufacturers of cough and cold medicines include labels on their products warning parents not to give them to children under age 2 without consulting a doctor. That suggests the medicines may cause some problems for very young children.

But, in fact, these medicines can be quite dangerous. The Centers for Disease Control and Prevention tells doctors to "exercise caution" before recommending them for infants and toddlers, mainly because there is scant evidence that they are effective and they can be harmful or even fatal in rare cases.

Such concerns led several leading Baltimore pediatricians, together with the city's health commissioner, Dr. Joshua M. Sharfstein, and some national pediatric experts, to petition the FDA in March to stop manufacturers from marketing their cold remedy drugs for infants and to require labels stating that the products are not safe for children under 6.

The petition links the deaths of four Baltimore children under age 4 to cough and cold medicines over the past six years. In addition to certain ingredients in the medicines, children are endangered by parents overdosing them when they don't respond quickly enough.

Increasing concerns - including those raised by Rep. Henry A. Waxman, who chairs the House Committee on Oversight and Government Reform - have helped persuade many drug manufacturers to voluntarily remove products for infants from shelves or to include labels that warn "do not use" for children under 2. But those actions have not been extended to protect children under 6.

That's why the FDA needs to step in quickly and remind parents and drugmakers that sometimes a cold or flu has to run its course and the best prescription is no medicine at all.

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