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Over-the-Counter Children's Cold Medicines Need More Study, Says FDA Panel

Oct 19, 2007 | Parker Waichman LLP

There is no evidence that over-the-counter cold remedies work for small children, and manufacturers of these products should subject them to clinical trials in order to prove their safety and effectiveness.  That was the conclusion of a Food & Drug Administration advisory panel convened to discuss the fate of these dangerous drugs. The panel concluded that adult data on over-the-counter medications could not be relied upon to show that these medications were beneficial for children.  The panel is still trying to decide if over-the-counter cough and cold medicines marketed to children should be subject to restrictions or labeling changes.

The FDA has been trying to decide what to do about over-the-counter children’s cold remedies since two studies questioned their safety. Earlier this year, research conducted by the Centers for Disease Control found that between 2004 and 2005, 1,500 children under the age of 2 had been injured by common over-the-counter decongestants and antihistamines.  A second study by FDA safety reviewers reached similar conclusions.  Their research found that from 1969 to 2006, at least 54 children died after taking over the counter decongestants, and 69 died after taking over-the-counter antihistamines.   And the FDA safety reviewers found little to convince them that over-the- counter cold remedies marketed for use in infants did anything to relieve cold symptoms. In September, the FDA issued a warning that these medications should not be used in children under 6.

Yesterday, the FDA panel heard from members of the American Academy of Pediatrics who want the agency to ban over-the-counter cold medicines marketed to children under six.  They told the FDA panel that there is no evidence that these medications even work in such young children, and there have a higher-than-usual frequency of overdoses associated with these over-the-counter cold medicines.  What’s more, none of the over-the-counter cold medicines available today have ever been tested for safety and effectiveness in children.  Rather, results of clinical trials done with adults were used to approve these drugs.

The FDA panel agreed with the pediatricians that children’s over-the-counter cold remedies have not been tested enough, and should undergo extensive clinical trials.  But the panel has yet to vote on the fate of these medicines.  However, some manufacturers have already decided to remove over-the-counter children’s cold medications from the market.  Last week, the Consumer Healthcare Products Association, a trade industry group, announced that 14 such drugs were being pulled.  The recall included Johnson & Johnson’s Tylenol Plus Cold, Novartis AG, Triaminic Infant & Toddler Thin Strips Decongestant, and one product sold by Wyeth under its Robitussin brand. Pediacare, Dimetapp and Little Colds brand products were also removed.

But despite last week’s recall, a representative from the Consumer Healthcare Products Association told the FDA panel that children’s over-the-counter cold medicines were safe.  Manufactures maintain that mistakes made by parents when they administer these medications were responsible for most of the injuries and deaths associated with over-the-counter cold remedies.


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