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Kids Under 2 Shouldn't Get OTC Cold Medicines, FDA Warns

Jan 17, 2008 | Parker Waichman LLP

Over-the-counter cold medicine is not safe for infants and children under two, the Food & Drug Administration (FDA) warned today.  According to the FDA, which has been reviewing the safety of the dangerous drugs for some time, over-the-counter cold medicines can have serious and potentially life-threatening side effects when given to the very young.

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.  In 2007, 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.

In October 2007, an FDA advisory panel had recommended that over-the-counter cold medicines not be taken by children under six.  Today’s public health advisory did not go that far, but the FDA said that it has not completed its review of these medications in children between the ages of 2 and 11. The FDA said that it is working to complete a review of the safety of over-the-counter cough and cold medicines in children 2 years of age and older as quickly as possible and expects to communicate new recommendations for these drugs in the near future.  

Until it completes reviewing the use of over-the-counter cold medicines in older children, the FDA suggests that parents check the “Active Ingredients” section on medication labels to be sure that no two drugs given to a child contain the same active ingredient.   Caregivers should carefully follow all directions on the “Drug Facts” section of the package insert, and use only the measuring device (cup or dropper) that is included with the medicine.  The products should not be used to make a child fall asleep, and they should be kept out of reach of children.

The FDA’s warning on over-the-counter cold medicines was not unexpected.   In fact, in a preemptive move, the manufacturers of some infant over-the-counter cold medicines chose to recall the products this past October.  Among the over-the-counter medications coming off the market are Johnson & Johnson’s Tylenol Plus Cold, Novartis AG’s 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 recalled.   In the public health advisory, the FDA praised the manufacturers of these products for the move to take them off the market.


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