Monday, October 1, 2007

FDA Takes Action To Stop Marketing Of Unapproved Hydrocodone Products

FDA informed healthcare professionals and consumers of its intent to take action against companies that market unapproved prescription products containing hydrocodone, a narcotic widely used as a coughsuppressant and to treat pain.

The drug has also 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 andjudgment. The FDA has received reports of medication errors associated withformulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products. Most of the hydrocodone formulations now marketed to suppress coughs have not been approved. The agency isparticularly concerned about improper pediatric labeling of unapproved hydrocodone cough suppressants (also known as antitussives), and the risk of medication error involving the unapproved products.

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 yearsof age. Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age 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 beforeMarch 31, 2008. Further legal action could be taken against those failing to meet these deadlines. There are a number of alternatives for patients who might be using unapproved hydrocodone cough suppressants. Consumers should consult ahealthcare professional for detailed guidance on treatment options.

Source: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Hydrocodone

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