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Companies marketing unapproved drugs that contain injectable colchicine to treat gout have 30 days to stop manufacturing and 180 days to stop shipping the drug, which has caused 23 reported deaths, according to the U.S. Food and Drug Administration.
All injectable colchicine drugs on the market 180 days after the FDA's announcement on Feb. 6 must have the agency's approval. Refusal could result in regulatory action, including seizure, injunction, or other legal action, according to the FDA statement. The enforcement measure marks the seventh action taken by the agency against companies marketing and selling unapproved drugs since issuing its Compliance Policy Guide. Colchicine tablets will remain on the market for now.
Injectable colchicine has been approved for treatment of gout in the U.S. since the 1950s. It is rarely administered because its use results in harmful adverse events or death.
For more information on the FDA's action, please go to http://www.fda.gov/cder/drug/unapproved_drugs/colchicine_qa.htm