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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Comments are posted from viewers like you and do not always reflect the views of this station.
  • by Ira Location: Hazard on Apr 2, 2009 at 02:14 PM
    You voted him in, now shut up belly aching. Hurt and enjoy who you voted for. When election time rolls around, vote for him again.
  • by Ridiculous Location: E Ky on Apr 2, 2009 at 12:35 PM
    You said "Give only in a hospital setting"!! How ridiculous is that? Do u think the only people that suffer are in hospitals? What would ur answer be to cancer patients? Have them take a glorified tylenol? There are REAL pains worse than cancer that REAL people suffer with EVERY DAY. I happen to be one of those. Do I take painkillers you ask? The answer is NO I do not because all that get them are the bunch of users & dealers that visit those glorified pain clinics which is a place I would never darken the door of. It totally astounds me as to the low life bunch that get over prescribed medications and people that truly suffer get sh_t & left to suffer. Do I sound angry?.. thats because I AM. Suffering is no fun and makes life HELL.
  • by Anonymous Location: ky on Apr 2, 2009 at 10:06 AM
    I agree I think pain meds should only be used in a hospital setting,if there not on the streets they can't sell them.
  • by Ruthie on Apr 2, 2009 at 04:28 AM
    They are making sure you have to pay top price for your dope.
  • by Bill Location: Ashland on Apr 1, 2009 at 08:35 PM
    Ban all pain meds off the market. Only sell tylenol and asprin and ibuprofen. Those will work fine. The only strong narcotics should be used within a hospital setting only...You send them home with a ice pack and tell them to get strong over the counter pain meds. This society today is suffering from so many drug addicts that are killing and hurting people over these drugs. Its ashame that it is all about money when it comes down to it... The upper politicians get the most of it...What a joke. I do notice when a politicians family member is affected from drugs being sold to their family member you notice how they start getting concerned about this issue. They dont worry until its them.

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