FDA: Cold And Cough Meds Could Hurt Kids

Very young children should not take some commonly used cold and cough medicines, federal health officials say in recommending that the "consult-your-physician" advice to parents on the labels be dropped.

The preliminary recommendation, from Food and Drug Administration safety officials, would apply to decongestant use in children under 2 years old and antihistamines in those younger than 6, according to agency documents released Friday.

The more than 350 pages of documents are part of a broad and continuing FDA examination of whether the roughly 800 medicines, many popular and widely used, are safe and effective in treating children's colds and coughs.

"Antihistamine-decongestant combination products," the FDA reports, "are no more effective for symptoms of....infection than placebo in young children." Overdoses were sometimes fatal, reports CBS News correspondent Wyatt Andrews. Between 1969 and 2006, 69 children died after taking antihistamines, and 54 died after taking decongestants.

FDA advisers are to take up the issue during an Oct. 18-19 meeting. The FDA has not decided on any label changes. Action probably is pending a recommendation from outside experts.

The review came in response to a recently filed petition by city officials from Baltimore, Maryland, who charged that many over-the-counter cough and cold remedies can harm toddlers and preschoolers. Those officials, joined by the American Academy of Pediatrics, cited evidence that suggests the drugs not only are risky but also do not work in the very young.

"The basic question is, why should a product be so relentlessly marketed when it's not safe or effective?" said Dr. Joshua Sharfstein, Baltimore's health commissioner. "It does not make sense, in the absence of information, to say 'consult a physician,' because they do not have superhuman powers. They cannot make a product safe or effective."

The Consumer Healthcare Products Association, which represents makers of over-the-counter medicines, said it recommends strengthening the labels on the medicines to help reduce misuse and confusion about their use in children, particularly in those younger than 2.

Among the deaths, most occurred in children younger than 2.

The Baltimore petition came in the aftermath of a Centers for Disease Control and Prevention report that found more than 1,500 toddlers and babies wound up in emergency rooms of U.S. hospitals over a two-year period because of the drugs.