The U.S. Food and Drug Administration (FDA) just announced that it warned four companies that they must stop marketing unapproved codeine sulfate tablets. These drugs are opioid analgesics, commonly called narcotics, and are widely used to treat pain.
These particular products have not received FDA approval and the agency has no evidence that they are safe and effective. Another manufacturer, Roxane Laboratories, markets FDA-approved codeine sulfate tablets and is able to meet the demand for the drug. The FDA does not anticipate a supply problem for codeine sulfate tablets.
“Consumers deserve and expect that their drugs meet modern FDA standards for safety, effectiveness, labeling, and quality. Removing unapproved products that do not meet those standards is an FDA priority,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA urges drug companies to ensure all drugs they make and market have appropriate FDA approval.”
The names of the products and the manufacturers and distributors that received the warning letters are:
- Codeine Sulfate Tablets, 30 mg, 60 mg: Lehigh Valley Technologies Inc., Allentown, Pennsylvania
- Codeine Sulfate Tablets, 30 mg, 60 mg: Cerovene Inc., Valley Cottage, New York
- Codeine Sulfate Tablets, 30 mg: Dava International Inc., Fort Lee, New Jersey
- Codeine Sulfate Tablets, 30 mg, 60 mg: Glenmark Generics Inc. USA, Mahwah, New Jersey
The FDA has allowed those companies receiving the warning letters 15 days to give the agency a plan to discontinue marketing the unapproved drugs. Manufacturers have 90 days to cease manufacturing of the new product, and distributors have 180 days to cease further shipment of existing products. Previously manufactured, unapproved products may still be found on pharmacy shelves for a period of time.
Today’s action is part of the FDA’s initiative against the marketing of unapproved drugs, announced in June 2006. At that time, the agency published a Compliance Policy Guide describing the FDA’s risk-based enforcement approach to unapproved products. “Doctors and patients often find that some drugs on the market do not have FDA approval,” said Deborah M. Autor, director of CDER’s Office of Compliance. “This lack of approval undermines the FDA’s process to ensure that safe and effective drugs are available to the U.S. public,” Autor added.
Consumers who rely on opioid analgesics for pain relief have access to products that have been evaluated by the FDA and determined to be safe and effective for use. There are other FDA-approved drugs, including different opioid analgesics, which can be used to relieve pain. Consumers should consult a health care professional for detailed guidance on treatment options.
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