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Doctors Urge FDA To Halt Cold Medication Sales For Children

October 2, 2008

In preparation for the upcoming cold season, pediatricians have called for the Food and Drug Administration to recall several over-the-counter cold medications for kids.

Some doctors worry that the drugs’ risks outweigh their benefits and have demanded a recall of the medicines for children younger than 6.

“Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children,” said Dr. Joshua Sharfstein, Baltimore’s health commissioner. “There is nothing that is holding the FDA back from asking for a voluntary recall now of products marketed to kids under 6.”

Overall, U.S. families spend at least $286 million each year on cough and cold remedies for children, according to the Nielsen Co. market research firm.

Doctors say the drugs are unnecessary because plenty of rest and fluids are the best cure for the common cold.

The FDA this year warned against giving OTC cold medicines to children younger than 2. At that time, officials said they expected to decide by spring on recommendations for youngsters up to 11. Now the agency is seeking more advice from doctors, industry and consumers.

The industry maintains that cold drugs have been used for many years and are safe for those older than 2. However, manufacturers are carrying out new studies involving the most common ingredients in the medications.

After the industry voluntarily stopped selling cough and cold medicines to babies and toddlers last fall, the FDA said more needed to be done to ensure the drugs were not used in children under the age of 6.

When the FDA set standards for cough and cold medicines some 30 years ago, no separate studies were done for kids.

Cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses.

The same ingredients usually are found in different products. For example, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.

The Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them.

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