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FDA Discourages Cough Syrup for Kids Under Age 6

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FDA Discourages Cough Syrup for Kids Under Age 6

Children's Health

FDA Discourages Cough Syrup for Kids Under Age 6

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From NPR News, this is ALL THINGS CONSIDERED. I'm Michele Norris.

Parents, listen up. Children ages 6 and younger should not be given over-the- counter medications for the common cold. That's the recommendation of an advisory panel to the Food and Drug Administration. The group did not recommend that these medications be taken off the market as manufacturers did with infant cold formulas just two weeks ago.

Joining us now from the FDA meeting outside Washington is NPR's Allison Aubrey. Allison, tell us more about what the panel is saying about these medications.

ALLISON AUBREY: Hey, Michele. What the panel is saying here is that there is not enough evidence to show these drugs are safe and effective for young children. And they're basically saying even though they've been used for almost 40 years now as over-the-counter drugs, that back then, when they were first put on the market, the FDA looked at data from adult populations. And they saw that these medicines were safe in adults.

And so they extrapolated the data and took lower doses and said, well, if this dose is safer and effective for adults, perhaps this lower level is safe and effective for kids. They never did test these medicines on kids. And today, basically what the panel is saying is if you want to say these medicines are safe and effective for kids, you've got to prove it. You've got to do more science. You got to do more research.

NORRIS: So we're talking about over-the-counter medications. What drugs specifically are we talking about?

AUBREY: So we're talking about three classes of drugs. We're talking about antihistamines such as Benadryl. We're talking about antitussives, which are cough syrups. We're talking about decongestants like Sudafed. And brand-wise, it's all of the brands that parents know of - Triominic, Pediacare. While we're not talking about Tylenol, as in the medicine, or Ibuprofen here, there are some products that are sold and marketed under the Tylenol label that include, not acetaminophen, but also these cold and cough medicines.

NORRIS: So you need to read the labels carefully?

AUBREY: That's right.

NORRIS: Now, we - these medications should not be given to children who are 6 and younger. What about older children?

AUBREY: Actually, the committee voted today that there shouldn't be limits for children 6 and older. And the basic reason for this is that when they actually looked at the data, when they actually looked at the data, when they looked at who have been harmed by these medicines in the past, where are the instances where kids are winding up in the E.R. or in the rare, rare event when there are deaths, they find that the most vulnerable population are the young children, not surprisingly. And so they weren't quite as concerned about older kids, where there aren't as many instances, documented instances of overdosing.

NORRIS: What kind of documentation do they have? Was there any evidence? Or what kind of evidence did they point to in making this recommendation?

AUBREY: They had lots. They had - on the side of where it's harm, they looked at hundreds of thousands of calls to poison centers. They looked at emergency rooms (unintelligible). They actually looked - when a serious event was reported, they followed up and they tried to find out what was really going on with the child when a cough and cold medicine sent them to the emergency room. And most instances - in most cases, they found that it really is overdosing. When these drugs were used in small doses, you weren't getting reports of kids in the E.R. The concern really about safety is how easy it is for parents to mistakenly overdose. And they do have lots of research about how often that happens.

NORRIS: Did they consider taking them off the market?

AUBREY: Actually, that is not what this panel was tasked with. These are, as you'll remember, independent advisers to the Food and Drug Administration. And they were asked to answer a technical question. The question actually read something like: based on our discussions here today on the efficacy and safety, are there any age groups for which these ingredients, these medicines should not be used? And so the panel answered that specific question. Whether or not they are taken off the market later is something that the FDA could decide.

NORRIS: NPR's Allison Aubrey. Thank, Allison.

AUBREY: Thank you very much, Michele.

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