Action should not affect consumers or lead to shortages, the agency says,,,,
TUESDAY, March 31 (HealthDay News) -- The U.S. Food and Drug Administration on Tuesday warned nine companies to stop making 14 unapproved prescription narcotic painkillers.
These unapproved products pose a risk for consumers, Deborah Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research, said during a morning teleconference. "These include respiratory depression and other serious adverse events, including death," she said.
The action is part of an ongoing effort to remove unapproved medicines from the market; roughly 2 percent of all prescriptions in the United States are filled with unapproved drugs, the FDA said.
This latest batch of warning letters tells the companies they could face enforcement action if they do not stop making and selling these unapproved drugs, including high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. Oxycodone capsules and approved tablets are not included in this warning, the agency noted.
"The FDA wants to assure consumers who rely on these products for pain relief that they will still have access to FDA-approved narcotic drugs and there will be no shortage for consumers," Autor said.
The companies have 60 days to stop manufacturing these products and 90 days to stop distributing them, Autor said. "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," she added.
The companies getting warning letters are: 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.
The market share of these unapproved pain products varies from product to product. One product slated to be removed from the market has about a 4 percent market share, while another unapproved product represents about 53 percent of the market, Autor said.
"Today's action is about 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," Autor said.
The FDA's pursuit of unapproved drugs began in 2006, and to date the agency's action has taken more than 500 unapproved drugs off the market from over 200 drug companies, Autor said. There are still several thousand unapproved drugs on the market, she added.
For more on unapproved drugs, visit the U.S. Food and Drug Administration.
SOURCES: March 31, 2009, teleconference with Deborah Autor, J.D., director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md.
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