FDA action on unapproved hydrocodone products

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.

Hydrocodone Risks
● Hydrocodone is one of the strongest medications available to treat pain or to suppress cough.
● The drug has been an extremely popular drug of abuse and can lead to serious illness, injury, or death, if improperly used.
● Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills and judgment.

FDA has received reports of medication errors associated with formulation changes in unapproved hydrocodone products, as well as reports of confusion over the similarity of the names of
unapproved products to approved drug products.

Alternatives for Patients
● There are a number of alternatives for patients who might be using unapproved hydrocodone cough
suppressants.
● Seven cough suppressant products containing hydrocodone are approved by FDA.
● A variety of approved cough suppressants do not contain hydrocodone.
● Consumers should consult a health care professional for detailed guidance on treatment options.

Improper Labeling
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.

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