TUESDAY, Oct. 2 (HealthDay News) -- By the end of 2007, companies must stop manufacturing and marketing unapproved prescription drug products containing the narcotic painkiller hydrocodone or face legal sanctions, according to a statement issued Sept. 28 by the U.S. Food and Drug Administration.
The FDA said the action was prompted by concerns about the improper pediatric labeling of unapproved hydrocodone cough suppressants and the potential for medication errors. Nearly 200 cough-suppressant products may be affected by the action.
According to the FDA, companies must stop further manufacturing and distribution of unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age by Oct. 31. Companies also must stop manufacturing any other unapproved hydrocodone drug products by Dec. 31 and must halt further shipment in interstate commerce by March 31, 2008.
"Companies marketing these unapproved products have not demonstrated the safety and efficacy of these drugs," Steven K. Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement. "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."
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