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FDA Advisers Urge Ban on Cold Medicines for Young Children
Date:9/29/2007

tion safety.

In announcing Friday's decision on hydrocodone, the FDA said it was prompted to take the action, because it had received reports of "medication errors associated with unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products."

Autor said that about 2 percent of all prescriptions written in the United States are for unapproved drugs. With some 200 unapproved drugs containing hydrocodone on the market, it's highly likely that most of the prescriptions for cough medicines that contain hydrocodone are for unapproved brands, she said.

Currently, the approved cough medications containing hydrocodone are: TussiCaps; Tussionex Pennkinetic; Hydrocodone Compound; Mycodone Homatropine Methylbromide; Hycodan; Tussigon; and Vicodin, she said.

According to the FDA, companies marketing unapproved hydrocodone products that are labeled for use in children younger than 6 years of age must stop manufacturing and distributing the products by Oct. 31.

Companies making other unapproved hydrocodone drug products must stop manufacturing such products on or before Dec. 31, 2007, and must "cease further shipment in interstate commerce on or before March 31, 2008."

The FDA said there are alternatives to unapproved hydrocodone-containing products. These include one of the seven approved cough medicines that contain hydrocodone as well as other cough suppressants that don't use hydrocodone.

More information

For more on drugs containing hydrocodone, visit the U.S. Food and Drug Administration.



SOURCES: Sept. 28, 2007, teleconference with Deborah M. Autor, director, Office of Compliance, Center for Drug Eval
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