FDA Alert on Pediatric Cough/Cold remedies

Chemar · 10-01-2007, 08:22 PM

http://www.fda.gov/medwatch/safety/2...tm#Hydrocodone

Quote:

http://www.nytimes.com/2007/09/29/he...=1&oref=slogin

FDA Warns on Hydrocodone in Pediatric Cough Suppressants, May Enforce Ban

The FDA says it will act against the improper use of hydrocodone in pharmaceutical products, especially in over-the-counter cough suppressants marketed for pediatric use.

The narcotic is widely used to treat both pain and coughs. Several products containing hydrocodone are marketed for children, and some contain dosing information for children as young as 2 years old, despite the fact that the drug has not been shown to be safe and effective in children under 6. The agency is particularly concerned over similarities in the names of approved and unapproved products.

Companies have until the end of October to cease manufacturing and marketing the unapproved pediatric products containing hydrocodone and until the end of the year to cease manufacturing and marketing other unapproved products containing the drug.

In addition, the New York Times reports that the FDA is considering an outright ban on OTC cold and cough medications for children younger than 6 years.

New York Times story (Free)

mrsD · 10-02-2007, 11:15 AM

and am a bit puzzled by it.

I have rarely seen cough prescriptions with hydrocodone given to children.
Once in a blue moon for a severe ear infection, I've seen Tylenol with Codeine given, and for broken bones, trauma.

But routinely? Nope.

Back in the old days, when mixtures were not made by drug companies, we used to compound Benylin expectorant (which has now been reformulated too) and doctor's would add codeine to it. We used codeine sulfate hypo tabs mixed in water added to the Benylin.

But hydrocodone for kids? I'd like to know where in USA this is happening.
Not in my area, for sure.

The concern for using ANY decongestant product in children below the age of 5 has been brewing for several years however...and I wonder if that article is just poorly written and means that too?

I personally have not seen an OTC hydrocodone product anywhere. So I am puzzled by that article!

mrsD · 10-11-2007, 01:11 PM

This story makes more sense to me...targeting all antihistamines and decongestants for 2 yr and under:

http://www.cnn.com/2007/HEALTH/10/11...ugs/index.html

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