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Administrator
Community Support Team
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Join Date: Aug 2006
Posts: 28,466
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Administrator
Community Support Team
Join Date: Aug 2006
Posts: 28,466
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FDA Alert on Pediatric Cough/Cold remedies
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)
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