FDA Orders Makers of Unapproved Pain Relievers to Stop

Four companies have been ordered by the Food and Drug Administration to stop making and selling illegal sulfate tablets used by millions of consumers for pain relief.

The drugs, also called opioid analgesics, have not been submitted to the FDA for review and approval, so there is no way to determine whether they are safe and effective, the agency said.

“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. “The FDA urges drug companies to ensure all drugs they make and market have appropriate FDA approval.”

The following products and the companies that make them are involved in today’s FDA warning:

• Codeine Sulfate Tablets, 30 mg, 60 mg – Lehigh Valley Technologies Inc., Allentown, Penn.

• Codeine Sulfate Tablets, 30 mg, 60 mg – Cerovene Inc., Valley Cottage, N.Y.

• Codeine Sulfate Tablets, 30 mg – Dava International Inc., Fort Lee, N.J.

• Codeine Sulfate Tablets, 30 mg, 60 mg – Glenmark Generics Inc. USA, Mahwah, N.J.

The FDA does not expect a shortage of codeine sulfate tablets as a result of the action taken against the four manufacturers because another company, Roxane Laboratories, has FDA approval to produce the drug and can continue to meet consumer demands, officials said.

“There are other FDA-approved drugs, including different opioid analgesics, which can be used to relieve pain,” the FDA said. “Consumers should consult a health care professional for detailed guidance on treatment options.”

The four companies that received FDA warning letters now have 15 days to tell the agency how they plan to stop marketing the illegal drugs. The manufacturers will have three months to stop making new products banned by the FDA and must stop shipping illegal products within six months, the FDA said.

Some illegal products that were made and distributed before the FDA action may still be available in pharmacies, the FDA cautioned.

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