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Consumer Update |
On Sept.28, 2007, FDA announced its intention to take enforcement action against companies marketing unapproved prescription drug products containing hydrocodone, a narcotic widely used to treat pain and suppress coughs. The action does not affect other hydrocodone formulations, which have FDA approval.
Some hydrocodone pain-relief products, such as Vicodin, are FDA-approved. However, most of the hydrocodone formulations now marketed to suppress coughs have not been approved. The agency is particularly concerned about improper pediatric labeling of unapproved hydrocodone cough suppressants (also known as antitussives), and the risk of medication error involving the unapproved products.
"Companies marketing these unapproved products have not demonstrated the safety and efficacy of these drugs," says Steven K. Galson, M.D., M.P.H., Director of FDA's Center for Drug Evaluation and Research (CDER). "A case in point – no hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 years of age."
Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years old must end further manufacturing and distribution of the products on or before October 31, 2007 .
Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before December 31, 2007 , and must cease further shipment in interstate commerce on or before March 31, 2008 . Further legal action could be taken against those failing to meet these deadlines.
Hydrocodone Drug Products Information
Date Posted: October 12, 2007