FDA Takes Action Against Unapproved Hydrocodone Products

The Food and Drug Administration (FDA) is taking action against those who are marketing unapproved products that contain hydrocodone in their formulas, they announced today, September 28, 2007.

In general, the Federal Food, Drug, and Cosmetic Act requires medication being marketed to undergo approval by the FDA to ensure it is safe and effective. However, some medications, mostly older ones, are still marketed illegally in the United States; that is, they do not have FDA approval. These medications may be advertised in medical journals and the Physician's Desk Reference and carry their own safety information.

Hydrocodone is a drug used for pain and to suppress cough. It is used to make Vicodin and in the formulas to make some cough syrups. According to the FDA, while Vicodin is an approved medication, many of the cough syrups being marketed to suppress cough are not approved by the FDA.

Hydrocodone use may impair judgment and motor skills and overdose of the drug may lead to cardiac arrest or breathing difficulties.

The FDA has received reports that there is some confusion among FDA approved cough medications and unapproved cough suppressants. Additionally, the FDA has heard reports of medication errors due to formulation changes in unapproved cough suppressants using hydrocodone.

The FDA's action against unapproved cough suppressants with hydrocodone is part of their initiative against all unapproved products, which was announced in June 2006. At that time, the FDA compiled a Compliance Policy Guide, describing the organization's approach to getting these products off the shelves.

Steven K. Galson, M.D., M.P.H., director for the FDA's Center for Drug Evaluation and Research asserts: "Companies manufacturing these unapproved products have not demonstrated the safety and efficacy of these drugs. 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 dosage instructions for children as young as 2 years of age."

The FDA is requiring that any manufacturer making and distributing unapproved hydrocodone products with labels with instructions for use in children younger than six years of age must stop making and distributing these products on or before October 31, 2007. Further, anyone who is manufacturing other unapproved hydrocodone products must stop making their products on or before December 31, 2007 and must stop dispersing their products through interstate commerce on or before March 31, 2008.

The FDA asserts that legal action may be taken against any company that does not stop making and/or distributing unapproved hydrocodone products on or before these set dates.

The FDA also reminds patients and physicians that there are seven cough suppressants with hydrocodone approved by the FDA and several other approved cough suppressants not containing hydrocodone that have been found to be safe and effective.

For more information on approved medication that has been found to be safe and effective by the FDA, please visit their website at: www.fda.gov.

Sources:

Food and Drug Administration: FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01713.html

Food and Drug Administration: Drugs Marketed in the United States That Do Not Have Required FDA Approval:
http://www.fda.gov/cder/drug/unapproved_drugs/