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    FDA Action Item Alert October 1, 2007
The following was posted on the FDA News web site on September 28, 2007: "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 cough suppressant 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 and judgment. The FDA has received reports of medication errors associated with formulation 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 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. 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 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 before March 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 a healthcare professional for detailed guidance on treatment options. A brief excerpt from the FDA’s News web site on this item is provided below: "The U.S. Food and Drug Administration today 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. There are a number of alternatives for patients who might be using unapproved hydrocodone cough suppressants. There are seven FDA-approved cough suppressant products containing hydrocodone. There also are a variety of approved antitussive products that do not contain hydrocodone. Consumers should consult a health care professional for detailed guidance on treatment options." Read the complete MedWatch 2007 Safety Summary including a link to the FDA News Release at: "http://www.fda.gov/medwatch/safety/2007/safety07.htm#Hydrocodone" |
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