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No Over-the-Counter Cold Medicine For Children Under Six, Says FDA Panel

Oct 22, 2007 | Parker Waichman LLP

A Food & Drug Administration (FDA) advisory panel has recommended that over-the-counter cold remedies should not be taken by children under 6.   The panel voted 13-9 to recommend that these defective drugs not be used for children between 2 and 6 because their safety and effectiveness has never been studied in kids.   And in a separate 21-1 vote, the panel also recommended that over-the-counter cold remedies not be taken by children under 2.   While the FDA is not obligated to follow the panel’s recommendations, it generally does so.   Thus, the votes could lead to big changes in how common cold symptoms are treated in young children.  

For years, pediatricians have been pushing the FDA to limit or restrict over-the-counter cold medicines marketed for very young children, complaining that these medications were too dangerous and ineffective in treating colds.  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.  Most of the danger comes from a high dosage or a combination of medicines given in a short period of time.   That can happen when a caregiver gives a child two medications – for example one to treat fever and another to treat a cough – without realizing that they contain some of the same active ingredients.

What’s more, over-the-counter cough remedies have never been studied to see if they were safe for young children.  When they were first approved in the 1970s, it was assumed that if the drugs were safe for adults, then smaller doses would be safe for kids.  Because of this, the FDA panel also recommended that over-the-counter children’s cold medicines be subject to clinical trials, and it also wanted dosing devices to be included with all medications.  The panel also recommended that dosing be standardized to reduce the risk of overdose.

The panel’s recommendations could mean a huge hit to the US cold remedy industry.  Already, some manufacturers have decided to remove over-the-counter children’s cold medications from the market.  Earlier this month, 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.

Following the advisory panel meeting last Friday, an FDA spokesperson told members of the media that it is unlikely that the agency would issue an all-out ban of over-the-counter cold medicines.   However, it is likely that the FDA will order labeling changes to warn of risks, and caution against the use of over-the-counter cold medicines in children under six.


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