The U.S. Food and Drug Administration says it will take enforcement action against companies marketing cough and pain medications for children that contain hydrocodone.
The agency says the narcotic has not been approved for treatment of coughs and colds in children, though it has been cleared for other, limited uses.
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, the FDA said.
Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills and judgment.
The FDA said it 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.
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 said it 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, Galson said.
The action is part of FDA's broader initiative on the marketing of unapproved drugs that was announced in June 2006.enforcement approach to these products.
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, the agency said.
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.