March 31, 2009

FDA acts against unapproved narcotics

The U.S. Food and Drug Administration is warning nine companies to stop manufacturing 14 unapproved narcotic drugs that are widely used to treat pain.

The FDA's warning letters notified the companies they may be subject to enforcement action if they don't stop manufacturing and distributing unapproved prescription drugs containing high concentrations of morphine sulfate, hydromorphone or oxycodone. The action does not include oxycodone capsules, officials said.

Consumers have a right to expect that their drugs meet the FDA's safety and effectiveness standards, said Dr. Janet Woodcock, director of the FDA's 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 said it determined removal of the unapproved narcotic products will not create a shortage for consumers.

Companies receiving warning letters are Boehringer Ingelheim Roxane Inc. of Columbus, Ohio; Cody Laboratories Inc. of Cody, Wyo.; Glenmark Pharmaceuticals Inc. of Mahwah, N.J.; Lannett Co. Inc. of Philadelphia; Lehigh Valley Technologies Inc. of Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group of St. Louis; Physicians Total Care Inc. of Tulsa, Okla.; Roxane Laboratories Inc. of Columbus, Ohio; and Xanodyne Pharmaceuticals Inc. in Newport, Ky.