The U.S. Food and Drug Administration has 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 is one of the strongest medications available to treat pain or to suppress cough. 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. As part of the drug approval process, the agency considers the possibility of medication errors and name confusion, so that potential safety issues associated with these factors can be minimized.
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," said Steven K. Galson, M.D., M.P.H., director of the 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."
Today's action is part of FDA's broader initiative on marketed unapproved drugs that was announced in June 2006. At that time, the agency published a Compliance Policy Guide describing the FDA's risk-based enforcement approach to these products.