No cold medicines to children under 6: FDA

October 19, 2007

Washington, DC - A Food and Drug Administration advisory committee has ruled that over-the-counter cold and cough medicines don't work for children under age 6 and giving the common medicine to young children cannot be recommended.

A Food and Drug Administration advisory committee has ruled that over-the-counter cold and cough medicines don't work for children under age 6 and giving the common medicine to young children cannot be recommended.

The panel of health experts looking at how safe and effective antihistamines, decongestants, antitussins and expectorants are in children said it is not appropriate to take data from adults and apply it to children under 12.

After a two-day hearing on the safety of the medicine, the panel called for more studies about how these drugs affect children.

Although the panel's recommendation is nonbinding, it could lead to changes in how cough and cold medicine is used.

During the meeting, the experts looked at a number of proposals, including whether multiple-symptom over-the-counter pediatric cough and cold medicines should be banned for children under 6 years old.

About 800 pediatric cough and cold products are sold in the United States, many using multiple ingredients that have been marketed for use in children for some 30 years.

Earlier this year, the FDA completed a review that found between 1969 and the fall of 2006 there were 54 reported child deaths from decongestants and 69 from antihistamines.