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FDA Cracks Down On Unapproved Narcotic Painkillers

WASHINGTON (AP) - The government ordered 14 unapproved narcotic
painkillers off the market Tuesday, prescription versions of potent
morphine, hydromorphone and oxycodone.

The Food and Drug Administration told nine manufacturers to quit
distributing the drugs within 90 days - but insisted there are
plenty of legal versions of the painkillers being sold for patients
who need relief.

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

The move is part of the FDA's years-long attempt to weed out
thousands of prescription drugs that sell despite never being
formally approved by the health regulatory agency. Many entered the
market decades ago, before federal law required such approval. The
FDA estimates that unapproved drugs account for 2 percent of all
prescriptions filled.

Tuesday, the FDA targeted unapproved versions of
high-concentrate liquid morphine sulfate and unapproved
immediate-release tablets containing morphine sulfate,
hydromorphone and oxycodone. Most are generic.

To help consumers tell if they have an approved or unapproved
version, the FDA posted both lists on its Web site:
http://www.fda.gov/cder/drug/unapproved-drugs/narcoticsQA.htm.

Manufacturers receiving warning letters Tuesday 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; Roxane Laboratories
Inc. of Columbus, Ohio; and Xanodyne Pharmaceutical Inc. of
Newport, Ky.

The largest, Boehringer, didn't immediately return a call
seeking comment.

Even FDA-approved versions of these painkillers pose a risk of
serious side effects, but the unapproved products add an extra
problem: Regulators haven't checked that those versions work as
well and are as pure as their approved competitors.

Companies that don't heed the FDA's deadline could face big
penalties: The government once seized $24 million worth of
unapproved drugs from a company that ignored a stop-selling order,
Autor noted.

(Copyright 2009 by The Associated Press. All Rights Reserved.)


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