Kids & Cold Drugs: Questions, Answers
Experts Answer Your Questions About Children's Cough and Cold Medicines
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
WebMD's message boards have buzzed with
questions and comments from concerned parents. To respond, WebMD spoke with
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
Your questions and the experts' answers:
When they say "cold and cough medications," what types of drugs are they talking about?
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
Aren't any of these types of drugs effective?
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.
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
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.