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FDA Advisers Urge Ban on Cold Medicines for Young Children
Date:9/29/2007

Review finds 123 deaths linked to the products since 1969

SATURDAY, Sept. 29 (HealthDay News) -- U.S. health experts on Friday urged the federal Food and Drug Administration to consider banning the sale of over-the-counter cough and cold medicines for young children.

The recommendation, from FDA safety officials, would apply to decongestant use in children under 2, and antihistamines in those younger than 6, according to agency documents released Friday, the Associated Press reported.

The products include approximately 800 popular medicines that are sold in the United States under names like Toddler's Dimetapp, Triaminic Infant and Little Colds, The New York Times reported.

FDA advisers will consider the recommendation during a meeting on Oct. 18 and 19, and will then offer their opinion to the full agency.

In the safety review released Friday, the FDA experts recommended that all infant cough and cold products be removed from the market. They also recommended that the sizes of the droppers, cups and syringes packaged with products be standardized to reduce the possibility of confusion and overdose, the Times said.

An FDA review of records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine, the AP said.

Most of the deaths were children younger than 2.

The Consumer Healthcare Products Association, which represents makers of over-the-counter medicines, backs the recommendation that the cold and cough treatments not be used in children younger than 2. As for antihistamines, the group recommends adding a warning that the drugs not be used to sedate young children, the AP sai
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