FDA to Weigh In on New Label for Cough Medicines A petition before the Food and Drug Administration could change the way parents care for children with colds. Many pediatricians cite a lack of evidence that cough medicines are safe or effective for young people.
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FDA to Weigh In on New Label for Cough Medicines

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FDA to Weigh In on New Label for Cough Medicines

FDA to Weigh In on New Label for Cough Medicines

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It's MORNING EDITION from NPR News. Good morning. I'm Steve Inskeep.


And I'm Deborah Amos.

Today in Your Health, cold medicines and kids. This month, advisers to the Food and Drug Administration will consider a petition to place a new warning label on pediatric cold and cough medicines - everything from Robitussin to Benadryl. The proposed label would tell consumers that the medicines should not be used in children age six and younger.

NPR's Allison Aubrey reports.

ALLISON AUBREY: Most moms would agree that a sick child can make for a horrendous night. Robin Wilner has been there.

Ms. ROBIN WILNER (Mother): You know, it's impossible for, you know, them to get to sleep or, you know, have a good night's sleep when they're cough, cough, coughing all night.

AUBREY: In these instances, Wilner says she uses over-the-counter cough medicines like Robitussin or Triaminic, and they seem to help.

Ms. WILNER: And it's, you know, definitely a temporary relief, but it certainly helps getting them to sleep and having a good - a better night's sleep.

AUBREY: Given this, a mother's own observations that the medicines seem to help, why is that pediatricians are increasingly advising against the use of cough and cold remedies?

Ian Paul is a pediatrician and researcher at Penn State. He says the benefits parents think they see from cough medicines is really nothing more than a placebo effect.

Dr. IAN PAUL (Penn State College of Medicine): I don't believe that these medications in the recommended doses are dangerous, but I don't believe they work.

AUBREY: Paul says when cold and cough medicines were approved for over-the-counter use in children back in the 1970s, manufacturers were not required to conduct studies to document their safety or their effectiveness.

This left Paul wondering about their effects, especially since he was constantly having to advise parents on using them. So five years ago, he and a group of colleagues conducted their own small study. They recruited the parents of 100 sick children and had them administer a single bedtime dose of medicine.

Some children got the real thing, a combination of dextromethorphan, a standard cough suppressant, and the antihistamine Benadryl. Other children, unbeknownst to both them and their parents, were given a placebo syrup. Paul says they compared symptoms to nights when children received no medication.

Dr. PAUL: Parents found that there was no difference between the two medicines or the placebo in how much their child coughed, how well they slept, how well the parents slept. None of those things were different between the two drugs and the placebo.

AUBREY: Given this research and three more small studies with similar conclusions, the American Academy of Pediatrics says cough suppressants should not be given to young children.

The academy first made the statement back in 1997, and since then there has been more research showing that neither decongestants nor antihistamines are effective in treating kids' cold-related symptoms.

But parents are still buying lots of these medicines. Cold and cough drugs are a $2-billion-a-year industry, and pediatrician Ian Paul says when he has families that are insistent upon using them, he tries to give them useful advice.

Dr. PAUL: I go through with them how to read the labels closely, follow the dosing instructions. I never recommend it for a child under age two because there are no dosing instructions and can't guide them on what dose to use.

AUBREY: But the task is more straightforward for children over two. The dose is written on the package. Still, each year three to four children die after unintentional overdosing. And in 2005, misdosing with cold and cough medicines led to more than 100,000 calls to U.S. poison centers.

The city health commissioner of Baltimore, Joshua Sharfstein, who's a pediatrician by training, says it's easy to get confused about how much medicine a child's taken.

Dr. JOSH SHARFSTEIN (City Health Commissioner, Baltimore): Sometimes the parent and the grandparent are both giving doses, or the mom and the dad or you're doing two products and not realizing because there's so many confusing names out there that they have the same ingredient in them.

AUBREY: For example, giving a child both a cold and cough syrup along with a nighttime flu product, not realizing that both have dextromethorphan. Sharfstein is petitioning the Food and Drug Administration to put a warning label on all cold and cough medications telling consumers that children six and under should not be taking these drugs at all. Sharfstein says the risk is too high, given the evidence that the medicines don't help kids feel better.

Mr. SHARFSTEI: In this case, there's no proven benefit.

AUBREY: The first step toward any policy action will come October 18th, when a group of advisers to the FDA meet to discuss the petition.

Allison Aubrey, NPR News.

AMOS: For advice on how to treat children's cold symptoms without cough medicines, go to npr.org/yourhealth.

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