U.S. to seek panel input on kids' cough, cold drugs

Wed Aug 15, 2007 3:09pm EDT
 
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WASHINGTON (Reuters) - A U.S. Food and Drug Administration advisory panel will discuss the safety and effectiveness of over-the-counter cough and cold medicines for children at a meeting in October, the FDA said on Wednesday.

"Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under 2 years of age," the Food and Drug Administration said in an advisory posted on its Web site.

The agency disclosed in March that it was reviewing use of the medicines in children.

A group of doctors and public health officials had filed a petition voicing concern that nonprescription cough and cold medicines were risky for children and not effective. Makers say the drugs are safe when used as directed.

The advisory panel, a group of experts from outside the FDA, is scheduled to meet October 18 and 19.

The committee discussion is to focus on several areas, including safety and efficacy, the basis for dosing recommendations and potential for unintentional overdose, an FDA meeting notice said. The FDA usually follows recommendations from advisory panels.

The FDA urged parents to follow directions on packages.

 

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