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Childrens' cold and cough medicines

On October 18, the FDA heard testimony from pediatric experts recommending that it ban some of the 800 pedicatric cough and cold products, containing combinations of 39 different drugs.  The pediatric experts agree that the medicines are largely ineffective in young children and can be dangerous for several reasons.  The drug industry would only acknowledge that deaths can result from accidental overdose and resisted the call to ban the products, preferring to limit the FDA to a call for voluntary educational services.  Pediatric medical witnesses pointed to the aggressive marketing of the medicines, often with infants depicted on the packaging, and the circumstances of delivery of the medicine (often in the middle of the night, in the dark, with one or more ill family members) and re-stated their opinion that educational programs would not be effective or adequate.

        As expected, on October 19, the FDA panel considering this issue called for a ban on childrens' cold medicines for use in children under six.  They acted on reports of rare but serious harm suffered by children, and the fact that there is no evidence that the medicines reduce cold symptoms in young children.    The vote to ban the medicines in children two and under was 21 to 1.  The vote to ban these medicines in children aged two through five was only 13-9, with most medical experts supporting the ban.   A consumer representative voted against the ban among older children because some of her friends use the medication to help their children sleep when ill.  Numerous medical speciailists and their academic societies also supported the ban.

Thompson O’Neil, P.C.
309 East Front Street
Traverse City, Michigan 49684
Toll Free: 1-800-678-1307
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