The agency is “revisiting the risk and benefits of the use of (cough syrups and cold medicines) in children,” Charles Ganley, director of the office of nonprescription drug products, tells The New York Times. “We’re particularly concerned about the use of these drugs in children less than 2 years of age.”

His remarks came after a petition was filed yesterday by a group of prominent pediatricians and public health officials demanding the FDA stop drugmakers from marketing cold and cough meds for children under age 6.

The petition says the med don’t work and, in rare cases, can cause serious injury. Popular elixirs such as Toddler’s Dimetapp, Infant Triaminic and Little Colds target kids as young as 2. Drugmakers say labeling contain warnings, but the petitioners argue overdoses are common when brands are mixed or small children are difficult to medicate.

The report cites this scary statistic: In a recent study of hospital emergency room records from 2004 and 2005, the CDC found that at least 1,519 children under age 2 had suffered serious health problems after being treated with common cough and cold medicines. Three of the children died, the disease control agency found.

One more troubling point: Ganley says most OTC remedies haven’t been adequately tested in children. The doses recommended on many of the products’ labels were no better than educated guesses. “We have no data on these agents of what’s a safe and effective dose in children.”

Now, let’s see if the FDA restricts usage and requires tests.

[tags]Citizen’s Petition, Cold Medicines, Cough Syrups, FDA[/tags]