U.S. health authorities warn about OTC cough and cold remedies for the under 2's

Jan 20 2008

Health authorities in the United States are again warning about the dangers of giving children over-the-counter (OTC) cough and cold medicines.

The Food and Drug Administration (FDA) says children under the age of 2 years should not be given such medicines as they are too dangerous for that age group.

The FDA says deaths, convulsions, rapid heart rates and decreased levels of consciousness, have been reported in rare cases in children younger than 2 years.

Dr. Charles Ganley, director of the FDA's Office of Nonprescription Products which reviews non-prescription drugs at the FDA, says serious and potentially life-threatening side effects can occur when young children under 2 years of age are given OTC cough and cold products; these include decongestants, expectorants, antihistamines and antitussives (cough suppressants) for the treatment of colds.

Dr. Ganley says the medicines have not been shown to be safe or effective in children under 2 and he says they treat only symptoms and will not cure a cold.

Although the cough and cold remedies have been sold for decades, there has been no requirement by the FDA for companies to prove they work for children.

The FDA is yet to decide if the widely sold medicines are appropriate for children of other ages and officials are currently evaluating data on their use in children age 2 to 11; Ganley says a decision will be made by spring.

The American Academy of Pediatrics (AAP) endorses the FDA's move and says children metabolize and react to medications differently than adults, often in unanticipated ways.

The AAP endorses the FDA's caution and says research shows that cough and cold products are ineffective in treating the symptoms of children under six years old and may pose serious risks.

The FDA has never endorsed the medicines being used with children under 2 and issued a warning last year against doing so without specific advice from a doctor.

While drug companies declare such products to be safe and effective when used as directed, last year 14 cough and cold products for children under 2 were voluntarily withdrawn.

This came at the same time a panel of FDA advisers recommended that non-prescription cough and cold medicines should not be given to children under age 6, following a petition from pediatricians and public health officials.

Ganley says despite the controversy engendering widespread publicity surveys later in the year showed many parents still felt the medicines were appropriate for children under 2.

The agency advises parents to carefully follow dosing directions on all OTC medications, to only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs, and to check product labels to make sure they are not giving more than one product with the same ingredient.

It appears that many of the problems reported in children were because of overdoses or accidental ingestion.

The Consumer Healthcare Products Association (CHPA), which represents over-the-counter drug makers, says it supports the FDA action.

The FDA recommends that anyone with questions contact a doctor, pharmacist or other health care professional to discuss how to treat a child with a cough or cold.