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FDA takes action against unapproved hydrocodone manufacturers

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WASHINGTON The Food and Drug Administration is taking action against manufacturers of unapproved prescription drug products containing hydrcodone, a narcotic widely used for the treatment of pain and suppressing coughs.

The agency 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 to approved drugs.

“Companies marketing these unapproved products have not demonstrated the safety and efficacy of these drugs,” said Steven Galson, director of the FDA’s Center for Drug Evaluation and Research. “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.”

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 Oct. 31. Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before Dec. 31, 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.

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