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Kids & Cold Drugs: Questions, Answers
Oct. 22, 2007 -- Would you give an over-the-counter cold or cough medicine to your 5-year-old child?
Before last week, most of us would have said "yes." Indeed, a 1994 study found that in a given month, more than a third of U.S. 3-year-olds were getting a dose of cold or cough medicine. Now more than 30 of these preparations are marketed for children.
But by a 13-9 vote, an FDA advisory committee says these medicines should never be given to kids under age 6. The FDA is not required to obey its advisory committees. Until the FDA acts, the products will remain on drugstore shelves (except for cough/cold products aimed at kids under age 2, which the industry voluntarily withdrew from market before the committee met).
WebMD's message boards have buzzed with questions and comments from concerned parents. To respond, WebMD spoke with two experts.
One is Ian Paul, MD, associate professor of pediatrics at Penn State Children's Hospital. Paul is a member of the American Academy of Pediatrics' executive committee on clinical pharmacology and therapeutics.
The other is Michael Shannon, MD, MPH, professor and chairman of emergency medicine at Children's Hospital Boston and Harvard Medical School. Shannon is one of the 16 leading pediatricians and public health experts who petitioned the FDA to stop the marketing of cough and cold medicines to young children.
Your questions and the experts' answers:
When they say "cold and cough medications," what types of drugs are they talking about?
Paul:
We are talking about four different medications. The first is a cough
suppressant, dextromethorphan or DM. Second are the decongestants, pseudoephedrine and phenylephrine.
Third is the expectorant, guaifenesin. And fourth are the antihistamines:
brompheniramine, chlorpheniramine maleate, diphenhydramine -- Benadryl -- and
others.
Aren't any of these types of drugs effective?
Paul:
None has been shown effective for children. There are some data showing that
pseudoephedrine, a decongestant, has some efficacy in adults. For the rest, the
data are pretty weak and the effect size is pretty small. There is mixed data
in adults, and you can question whether this means there it is a clinically
significant effect. But those tested in children are not shown to be superior
to inactive placebo.
Shannon:
The fact of the matter is, regardless of age, cough and cold preparations are
ineffective. There is one study in adults, that the industry produces, showing
that if you give cough and cold medicine to an adult you can expect about a 6%
improvement. That is pretty doggone small. I interpret that and the rest of the
medical literature to mean these products don't work in older children or
adults, either.
In our petition we were interested in children under age 6 because there is where we saw the most problems, particularly in those under 2 years of age. The FDA panel chose not to take a position on children over 6, but in our petition we didn't ask them to. When they asked us, we said these medications are still not effective, but may be a little safer in older children.
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