New warnings about cold remedies for kids |

New warnings about cold remedies for kids

Parents of young children who are using over-the-counter medications to treat coughs and colds this winter should think twice after a recent announcement from federal regulators strongly discouraging such products for children younger than 2.

The Food and Drug Administration said in a public health advisory that “serious and potentially life-threatening side effects” can occur when children in this age group are given popular cough and cold products such as Dimetapp, Pediacare, Triaminic and Robitussin.

The FDA also said it has no reliable data showing that these medications actually work in young children.

Before the announcement, drug makers already had voluntarily withdrawn these products from use in children younger than 2. But the medications continue to be sold for older children, and some of them still are ending up in very young children despite the withdrawal.

The reason for the concern is clear: Over the years, these products have been heavily marketed as safe and effective, with some even claiming they are “pediatrician-recommended.” More than $50 million was spent in the 2007 fiscal year alone promoting these preparations to parents.

But not one major study of cough and cold products in children younger than 12 has shown any benefit in relieving symptoms when compared with a placebo.

At the same time, these medications have generated more than 750,000 calls to poison-control centers since January 2000. One recent study showed that more than 1,500 children required emergency-room treatment because of the drugs during a two-year period.

Adverse effects in children have included abnormal heart rhythms and other cardiovascular events, hallucinations and depressed levels of consciousness. An FDA review identified 123 deaths in children younger than 6 related to the use of these products over several decades.

Given these risks, many pediatricians and others don’t think the FDA’s recent action goes far enough. They are calling for the agency to force drug companies to remove these products from store shelves, or at least extend the recommendation against use to age 12.

The FDA says it now is reviewing data regarding the use of these medicines in children ages 2 to 11 and will make further recommendations soon. In the meantime, it is asking parents who give these products to children in this age group to follow the dosing instructions on the package label carefully.

Undoubtedly, many parents will find the new recommendations hard to swallow. Before the FDA announcement, about 95 million packages of over-the-counter cough and cold medications for children were sold in the United States each year.

Without these medications, what is the parent of a sick child to do?

To relieve a stuffy nose, parents can thin the mucus with saline nose drops. They shouldn’t use drops that contain any medicine. A cool-mist humidifier in the child’s bedroom also will help to clear nasal passages.

To bring down a fever, parents can give their children acetaminophen or ibuprofen. They should check with the child’s health-care provider for the right dosage for the age and size of the child.

To prevent dehydration, parents can make sure their child drinks lots of fluids. Clear liquids usually are a better choice than milk or formula while the infection is running its course.

Of course, the child also should get plenty of rest. If symptoms don’t resolve quickly, or if they seem to be getting worse, parents should call the child’s health-care provider.

” Jason Eberhart-Phillips, M.D., is the El Dorado County health officer. He can be reached at

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