Resources for Food and Drug Administration (FDA)

FDA Divided On OTC Cold-Cough Medicine Use In Children

money.cnn.com

A top Food and Drug Administration official said Thursday the agency is divided about whether over-the-counter cold and cough medicines are safe and effective for use in children ages 2 to 11.

But, Charles Ganley, FDA's office of nonprescription director, said the agency would make a decision about whether any restrictions or labeling changes are needed in the next few months, which would be in time for manufacturers to make any labeling or marketing changes for the 2008-2009 cold and cough season.

For now, the FDA is reminding parents not to use the medicines in children younger than age 2 amid concerns parents are still using products aimed at older children and adults in babies and toddlers. In a public health advisory issued Thursday, the FDA said, "serious and potentially life-threatening side effects can occur."

The agency has never approved cold and cough medications for children younger than age 2, and last October over-the-counter cold and cough makers voluntarily pulled products marketed to babies and toddlers ahead of an FDA panel review of children's cold and cough products.

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