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FDA to Parents: Do Not Give Tots Cough and Cold Meds

The Food and Drug Administration warns that over-the-counter medications can produce potentially life-threatening side effects



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The Food and Drug Administration this week issued a stern health advisory once again warning parents not to give babies under two years of age over-the-counter (OTC) cold and cough medicine because of potentially "serious and life-threatening side effects." This includes decongestants, expectorants, antihistamines and antitussives (cough suppressants) that you can pick up at pharmacies and supermarkets, including Wyeth's Robitussin, Novartis, AG's Triaminic and Johnson & Johnson's Tylenol Plus Cold.

"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than two," Charles Ganley, director of the FDA's Office of Nonprescription Products said. "These medicines, which treat the symptoms and not the underlying condition, have not been shown to be safe or effective in children under two."

The announcement comes on the heels of a high-profile meeting last October at which experts warned of dangerous side effects in children and recommended they not be given to those younger than six years old. Besides fatalities, adverse effects reported include convulsions, rapid heart rates, and reduced levels of consciousness.

The FDA noted in its public advisory that it is "aware of reports of serious side effects" in children between two and 11 years old, but is still reviewing information about risks in that age group. The agency in August warned parents not to give over-the-counter cough and cold remedies to tykes under two years old, but issued the current alert because it was worried parents did not get or heed the message.

After last year's huddle, many drug companies voluntarily pulled 14 cough and cold products targeted at toddlers from store shelves. The FDA in the past has not required pharmaceutical manufacturers to prove the elixirs, which have been sold for decades, work in children, allowing dosing to be gleaned from adult data. But pediatricians have been  increasingly concerned about the safety of these products in their young patients.

"Children metabolize and react to medications differently than adults, often in unanticipated ways,'' the American Academy of Pediatrics said in a statement released after the FDA alert. "Studies have shown cough and cold products are ineffective in treating symptoms of children under six years old and may pose serious risks.''

Physicians have suggested using old-fashioned remedies to help ease cold symptoms, including drinking lots of fluids (among them, Mom's favorite chicken soup), humidifiers and rubbing babies' backs in a steamed-up bathroom.

The FDA is expected to rule by the spring on whether the drugs should also be nixed for kids between the ages of two and 11. In the meantime, it cautions parents who use them in that age group to, among other things, carefully follow dosing directions, only use measuring spoons or cups that come with or are specifically designed to be used with the drugs, and remember that the drugs, at best, temporarily mask symptoms of but neither cure nor shorten the duration of colds or coughs.

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