The Food and Drug Administration on Tuesday warned nine manufacturers for illegally making powerful prescription drugs used to treat sever pain. The companies have 60 days to stop making these products and 90 days to stop distributing them, if they want to avoid further enforcement action.
“FDA expects all manufacturers and distributors of unapproved versions of these products to honor these deadlines and will not tolerate any manufacture or distribution after these deadlines,” Deborah Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research, said.
The drugs involved are high in morphine, a powerful painkiller and hydromorphine or oxycodone, ingredients that pose an increased risk for respiratory distress and other serious adverse events, including death in patients, if not used properly. There are fourteen such drugs. No oxycodone capsules are involved in the action.
Companies manufacturing these drugs and getting a warning were: Boehringer Ingelheim Roxane Inc., of Columbus, Ohio; Cody Laboratories Inc., Cody, Wyo.; Glenmark Pharmaceuticals Inc., Mahwah, N.J.; Lannett Co., Philadelphia; Lehigh Valley Technologies Inc., Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group, St. Louis; Physicians Total Care Inc., Tulsa, Okla.; Roxane Laboratories Inc., Columbus, Ohio; and Xanodyne Pharmaceuticals Inc., Newport, Ky.
Autor wanted to assure patients that they will still have access to FDA-approved narcotic drugs and there will be no shortage following this warning. The agency’s move is a step forward in “ensuring that Americans have safe and effective drugs and getting the message to companies that they have a responsibility to patients that they should actively pursue FDA approval for their illegally marketed products,” she added.
The FDA started its fight against unapproved-drugs in June 2006 and since then, 200 firms and 900 drug products have been subject to FDA actions. Even so, there are still several thousand unapproved drugs on the market.
“There is no specific information on safety concerns. But lack of assurance of purity and quality raises questions. These manufacturers have not submitted data to FDA that guarantee the safety and purity of their products,” Autor said about manufacturers included in the latest FDA action.
She also said that these manufacturers face big penalties if they fail to meet the agency’s deadline. The government once seized $24 million worth of unapproved drugs from a company that ignored a stop-selling order.
People who want a list of the drugs involved in this action should access the
FDA’s Unapproved Drugs Web page. If they are taking one of the unapproved drugs listed there they should see their health care professionals for treatment options.
