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FDA warns makers of unapproved narcotics

  • Story Highlights
  • FDA warns manufacturers they have 60 days to pull unapproved drugs from market
  • Officials don't know if drugs are unsafe; they have never been approved
  • Removing unapproved drugs not expected to create a shortage of pain relievers
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By Val Willingham
CNN Medical Producer
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WHITE OAK, Maryland (CNN) -- Seeking to remove unapproved drugs from the marketplace, the Food and Drug Administration on Tuesday ordered nine companies to stop manufacturing narcotics whose therapeutic claims have not been proved.

The FDA ordered nine companies to stop selling unapproved drugs marketed for pain relief.

The FDA ordered nine companies to stop selling unapproved drugs marketed for pain relief.

The FDA's warning letters notified the companies they may be subject to legal action if they do not stop manufacturing and distributing "prescription unapproved products" that include high-concentrate morphine sulfate oral solutions and immediate-release tablets containing morphine sulfate, hydromorphone or oxycodone.

This action does not include oxycodone capsules. All of these drugs are used for pain relief and are forms of previously approved medications.

The agency says this is not a recall, but is instead a warning to manufacturers. The companies have 60 days to pull these pain-relief drugs from the market. Distributors have 90 days to stop shipping them.

If these drugs are not off the market by those deadlines, a company could face seizure of the narcotics and legal action.

"We estimate there are several hundred unapproved drugs out there," said Deborah Autor, director of the office of compliance within the FDA's Center for Drug Evaluation and Research.

"We will continue to take aggressive action against those firms that do not have the required FDA approval for their drugs. Today's warning letters are another demonstration of our commitment to remove illegal, unproved drugs from the market."

Although the FDA does not know whether these drugs are unsafe, it has not approved them so cannot certify that the products are 100 percent safe and effective.

"Consumers have a right to expect that their drugs meet the FDA's safety and effectiveness standards," said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research.

"Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality."

The FDA believes Americans have access to plenty of legal narcotics for pain relief and removing these unapproved drugs will not create a shortage.

Consumers who may be concerned that they are taking any unapproved drug products should refer to the FDA's Unapproved Drugs Web page, which includes a list of manufacturers of these products. Those who find they are taking unapproved drugs should see their health care professionals for treatment options.

Those companies receiving warning letters are Boehringer Ingelheim Roxane Inc., Columbus, Ohio; Cody Laboratories Inc., Cody, Wyoming; Glenmark Pharmaceuticals Inc., Mahwah, New Jersey; Lannett Company Inc., Philadelphia, Pennsylvania; Lehigh Valley Technologies Inc., Allentown, Pennsylvania; Mallinckrodt Inc. Pharmaceuticals Group, St. Louis, Missouri; Physicians Total Care Inc., Tulsa, Oklahoma; Roxane Laboratories Inc., Columbus, Ohio; and Xanodyne Pharmaceuticals Inc., Newport, Kentucky.

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