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FDA Hears Testimony On Children's Cold Medicine

PITTSBURGH (KDKA) ― Parents will do anything to make a sick child feel better. And sometimes they will reach for over-the-counter cough and cold medicines - drugs that have been available for decades.

The Food and Drug Administration is hearing testimony today that could push a change to make these drugs harder to get.

The FDA recommended earlier this year that children under two not take over-the-counter cold medicines.

"Some of these medicines, especially in some of the very young kids, may actually cause harm," says Dr. Raymond Pitetti, an emergency room physician at Children's Hospital, "and there have been a number of deaths due to over-the-counter cold medicines."

A review of records between 1969 and 2006 shows 69 deaths associated with antihistamines, diphenhydramine, brompheniramine, and chlorpheniramine -- active ingredients in many cold medicines. Most of the deaths involved children younger than two.

Doctors and consumer advocates are telling the FDA to ban over-the-counter sales of these products. Industry representatives say they are safe if used as directed.

"The problem is a lot of these drugs don't work very well, even if you had access to them, so it's a tough situation," acknowledges Dr. Pitetti.

A mistake in the correct pediatric dosage can increase the risk of stroke, seizures and other complications.

If it becomes less convenient to get these drugs for their child's runny nose, cough and congestion, some parents may wonder what to do.

"Cool mist, humidified air, and lots of fluids. Those are simple things you can do at home for colds and upper respiratory infections," Dr. Pitetti says.

To pharmacist David Hairhoger, more restricted access would be a good thing. "In a practical sense, it may be a good idea for that to happen. It will eliminate the danger of choosing an inappropriate medication, or someone not following directions."

The FDA could further restrict the use of these products in children, or it could recommend that the products go through clinical trials involving children -- both of these measures could takes years to accomplish. The FDA could also issue a parental advisory about these medicines.

(© MMVIII, CBS Broadcasting Inc. All Rights Reserved.)

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