Panel Makes Recommendation on Cold Medicines

An advisory panel recommended to the Food and Drug Administration this week that cold medicines be banned for children under the age of six. Dr. Danny Benjamin, a research professor at Duke University, who is also a practicing pediatrician and has worked in the past as an advisor to the FDA, speaks with Liane Hansen.

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LIANE HANSEN, host:

From NPR News, this is WEEKEND EDITION. I'm Liane Hansen.

The coming cold and flu season just became more difficult for parents of young children. It used to be that when your child had a cold and was coughing and sneezing, you could try to lessen the discomfort with a teaspoon of children's cough medicine. Well, you'll want to think twice before you do that now.

An advisory panel of the Food and Drug Administration is recommending that over-the-counter cough and cold medicines should not be given to children under six. The committee says manufacturers should conduct clinical trials to show the medicines actually work for children.

Dr. Danny Benjamin is a pediatrician and a research professor at Duke University. He's also worked as an advisor for the FDA, and we've reached him by phone.

Welcome to the program.

Dr. DANNY BENJAMIN (Pediatrician; Research Professor, Duke University): Thank you.

HANSEN: How dangerous are these children's cough and cold medicines?

Dr. BENJAMIN: For the individual child, the danger is low. But when given across millions of children across large segments of the population, which they are, rare serious adverse events can occur. And combined with the fact that the products probably don't work, that's why I think the committee made the recommendation that they did. They don't do any good and there is a very small risk. That's really unacceptable.

HANSEN: What do you mean they don't work?

Dr. BENJAMIN: Well, when these products were originally licensed, they were tested and found to be effective in adults but were never appropriately tested in children. And so at that time, the standard was for the Food and Drug Administration to simply divide the dosage in adults by 70 - say that that was the appropriate dose per kilo for a child.

The problem with that is that children often metabolize or process drugs very, very differently than adults. And these products were not ever tested to see if that was the case. And they were never tested to see if the safety parameters were the same in children. And they were never originally tested to see if they worked in children.

HANSEN: Well, the drug makers maintain that their products are safe and effective, and almost all of the deaths reported had been due to overdose. So how could the manufacturers prove that that is in fact the case?

Dr. BENJAMIN: Well, it's not very difficult for them to take a little bit of time and effort to prove that the drugs are effective. And it's not very difficult for them to prove that they're safe. And it's certainly not difficult at all to do appropriate dosing. But they haven't taken the 35 years that they've been making money from these products to do the right thing for children and test them appropriately. It would involve clinical trials. And for efficacy and for dosing and for most of safety, it would involve relatively small trials.

HANSEN: One expert told the FDA panel that kids catch five to eight colds per year. You're a pediatrician. Do you have kids?

Dr. BENJAMIN: Yes, ma'am. I have four children.

HANSEN: How old are they?

Dr. BENJAMIN: They are seven, six, two and eight months.

HANSEN: What do you do for your own kids when they get a cold?

Dr. BENJAMIN: Well, the most important thing that we can do for these children is tender loving care. This is going to last for a few days. It's probably going to get a little bit worse. There are going to be some very uncomfortable nights at home. But this will resolve.

And the first cold in the first year of life is almost always the worst. And in those circumstances - lots of tender loving care, plenty of fluids for the babies. And for the older kids, you can elevate the head of their bed a little bit. A cool mist vaporizer in the room, saline nose drops. And that if the children get much worse, certainly to have the child seen by a pediatrician.

HANSEN: You know, when love was offered as an effective treatment to the panel, there are a lot of snickers in the room over that.

Dr. BENJAMIN: Well, if we show compassion for these young children when they are feeling a little uncomfortable and they are certainly very scared, that goes a long way to alleviating their discomfort. In fact, that's been studied.

HANSEN: You think this winter there's going to be a big spike in chicken soup sales?

(Soundbite of laughter)

Dr. BENJAMIN: Well, it's pretty standard at our house. So we don't use cold medicines at home. I certainly don't advise that for any of my patients. I think that lots of hand washing, lots of comfort and reassurance. The solution of tender loving care might elicit snickers but it's not killing anyone.

HANSEN: Dr. Danny Benjamin is a pediatrician and a research professor at Duke University. He also worked as an adviser for the FDA.

Thank you so much.

Dr. BENJAMIN: Thank you, ma'am.

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