April 1, 2009

Crackdown On Illegal Painkillers

The Food and Drug Administration told nine manufacturers to quit distributing 14 unapproved narcotic painkillers drugs within 90 days.

Yet, federal regulators insisted there are numerous legal versions of the painkillers for patients who need relief.

"There will be no shortage for consumers," said Deborah Autor, director of FDA's drug compliance office.

The government ordered unapproved prescription versions of potent morphine, hydromorphone, and oxycodone off the market.

The FDA estimates unapproved drugs make up 2 percent of all prescriptions filled.

Federal officials put their focus on unapproved versions of high-concentrate liquid morphine sulfate and unapproved immediate-release tablets containing morphine sulfate, hydromorphone and oxycodone.

The affected manufacturers received warning letters on Tuesday.

The companies include 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; Roxane Laboratories Inc. of Columbus, Ohio; and Xanodyne Pharmaceutical Inc. of Newport, Ky.

The FDA says unapproved products have not been checked by regulators and therefore have not been proved to work as well as competitors.

Companies that don't comply with the deadline could face big penalties.

Federal regulators once seized $24 million worth of unapproved drugs from a company that ignored a stop-selling order, according to Autor.


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