From: Reuters
Published February 6, 2008 03:45 PM

FDA says 23 deaths linked to unapproved drug

WASHINGTON (Reuters) - U.S. regulators said on Wednesday they would crack down on marketing of an unapproved injectable anti-gout drug which has been linked to 23 deaths.

The Food and Drug Administration said injected forms of the drug, colchicine, can be highly toxic, and may lead to organ failure and death in excessive doses.

The FDA said the manufacturers, which it did not name, must stop shipping the product within 180 days or face enforcement action that could include seizure, injunction or other legal measures.

The medicine has become popular in alternative medicine and has been used for back pain, the FDA said. The agency strongly cautioned against that use, saying the risks outweigh any benefits.

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Three of the deaths identified were due to a miscalculation in dosing, in which patients were given doses eight times more potent than recommended.

The move does not impact oral forms of colchicine, sold in approved versions by generic drugmakers Watson Laboratories and Ivax, a unit of Teva Pharmaceutical Industries of Israel. They are used to treat gout, an inflammatory condition marked by pain and swelling of the joints.

(Reporting by Kim Dixon; Editing by Tim Dobbyn)

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