FDA panel: No cold medicines to children under 6

[Shannon]

WASHINGTON (CNN) -- Over-the-counter cold and cough medicines don't work for children under age 6 and giving the common medicine to young children cannot be recommended, a Food and Drug Administration advisory committee said Friday.


An FDA panel has called for more studies on how cold medicines affect children.

The panel of health experts looking at how safe and effective antihistamines, decongestants, antitussins and expectorants are in children said it is not appropriate to take data from adults and apply it to children under 12.

After a two-day hearing on the safety of the medicine, the panel called for more studies about how these drugs affect children.

Although the panel's recommendation is nonbinding, it could lead to changes in how cough and cold medicine is used.

During the meeting, the experts looked at a number of proposals, including whether multiple-symptom over-the-counter pediatric cough and cold medicines should be banned for children under 6 years old.


About 800 pediatric cough and cold products are sold in the United States, many using multiple ingredients that have been marketed for use in children for some 30 years.

Earlier this year, the FDA completed a review that found between 1969 and the fall of 2006 there were 54 reported child deaths from decongestants and 69 from antihistamines. Watch one family's tragic ending »

Most of the deaths occurred in children under 2.

In August, federal health officials recommended the "consult your physician" advice to parents on the labels of cold and cough medicines aimed at young children be replaced by a warning not to use the medications in children under 2 unless directed to do so by a health care provider.

Before the FDA hearings, some of the leading manufacturers of cold and cough medicines announced a voluntary recall of more than a dozen cold medicines for infants.

The Consumer Healthcare Products Association said the products were being pulled "out of an abundance of caution."

Potential misuse of the medications, not product safety, is driving the voluntary withdrawal, the group said.

The American Academy of Pediatrics applauded last week's decision to pull those products saying, "These medicines are ineffective and can have serious side effects. There are other ways to treat cold symptoms."

When the drug industry voluntarily withdrew products last week, it insisted that when used as directed, the drugs are safe, and they work. "Parents can continue to trust over-the-counter cough and cold remedies for their children," said Linda A. Suydam, president of the Consumer Healthcare Products Association.

"We strongly encourage parents to adhere to the recommended dosing instructions for all medicines, recognizing that the vast majority of adverse events associated with their use are due to inadvertent overdosing and misuse."

Suydam said CHPA will be launching a major educational campaign for parents and caregivers in coming months.

Baltimore Health Commissioner Dr. Joshua Sharfstein headed the push that led to the FDA hearing. He became alarmed when four Baltimore children died after their parents gave them excessive doses of cold medicines.

Until those deaths, he did not realize that a dose of cold medicine could turn into a life-and-death issue among young children, he said.

[Shannon]

http://www.cnn.com/2007/HEALTH/10/19/coldmed.fda/index.html