August 15, 2007

FDA: Stop Giving Cold Medicine To Kids Under Two

Last spring, a group of pediatricians petitioned the FDA to finally conduct a formal safety review of cough and cold medicines for kids under two years old. [The FDA had resisted for decades in large part because of the longstanding popularity of the drugs. With no scientific basis beyond tradition, they were assumed to be plenty safe. Also, pharmas sell $2 billion of the stuff each year.]

Anyway, the Agency has agreed to conduct a review in October. In the mean time, though, they came out with this announcement:

Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used. To avoid giving a child too much medicine, parents must carefully follow the directions for use of the product in the “Drug Facts” box on the package label.
So DON'T give your kid too much medicine, too frequently, and read the labels? Right. Good ideas.
What should parents know about using cough and cold products in children?

Do not use cough and cold products in children under 2 years of age UNLESS given specific directions to do so by a healthcare provider. [emphasis and ALLCAPS all theirs]

Wait, what? I know it's just a call to a nurse away, but still, I'm confused.

If a government agency that admits to making regulatory decisions without any actual scientific or research basis comes out with a sweeping, stopgap, internally conflicted change of position on cold medicine in August, does it make a credibility problem?

F.D.A. Limits Children’s Cold and Cough Medicines
[nyt]
Public Health Advisory: Nonprescription Cough and Cold Medicine Use in Children [fda.gov]

Previously: Children's Cold Medicines Are [Check All That Apply]: Untested, Useless, Potentially Dangerous

2 Comments

That is a little bit iffy! However I think it's a good idea for sure. I know so many parents who abuse the use of that stuff and then when they really need it of course it doesn't do a darn thing to help. I know a woman who gave her 18 month old tylenol COLD all spring for an ALLERGY cough. Well when she mentioned this to her ped he nearly flipped his lid because of course too much medicine over a long period of time can cause liver/kidney/and other type of unwanted damage.

I don't remember taking medicine for "colds" when I was little and I certainly don't now unless a cough keeps me up at night.

The pharmaceuticals should stop marketing some of their cough/cold medicines under the "Infant" label. On the back it still says "Children under 2: consult your doctor" even though it is supposed to be for "infants."

I assume the term infant is not regulated and for the pharmas it is okay to call a 3yo kid an infant. I don't think common Joe and Jane agree with that.

I am surprised, though, that Dr. Sears is actually okay with such meds. See these links for example: ROBITUSSIN-DM INFANT DROPS and PEDIACARE INFANT'S DECONGESTANT PLUS COUGH DROPS.

[we use that Dr Sears list of infant (sic) medicine regularly to cross-check active ingredients and dosages. If I believe/admit that there's a lot of parents who just blithely give infants medicine without checking much of anything beyond the "trusted" brand name and the flavor, I have to support the FDA's recommendation on this, even if we don't abide by it our conscientious selves. -ed.]

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