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FDA intents to take enforcement action against companies marketing unapproved injectable colchicine, a drug used to treat gout.
Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure.
"Today's action supports our ongoing efforts to end the marketing of unapproved drugs with serious health risks," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research (CDER). "Such products put consumers' health and sometimes their very lives at grave risk. It is a priority that these products be removed from the market."
Individuals and companies must stop making these products within 30 days and stop shipping the product within 180 days or face regulatory action which could include seizure, injunction or other legal action deemed appropriate by the agency. After these dates, all injectable colchicine drug products must have FDA approval to be manufactured or shipped interstate.
In June 2006, the FDA began taking action against marketed unapproved drugs. That effort seeks to ensure that all drug products marketed in the United States are shown, through the drug approval process, to be safe and effective and to meet appropriate standards for manufacturing and labeling. The agency published a Compliance Policy Guide (CPG) in June 2006 that describes the FDA's risk-based enforcement approach to marketed unapproved drugs. This represents the seventh action taken by the agency against companies that market and sell unapproved drugs since issuing its CPG.
"Until recently, there was one manufacturer of unapproved injectable colchicine, and that firm has ceased manufacturing the product," said Deborah Autor, director of the FDA's Office of Compliance, CDER. "This serves as the agency's warning that firms wishing to make injectable colchicine in the future must not manufacture the product until they apply for and are granted approval by the FDA to do so."
In addition to being manufactured by pharmaceutical companies, injectable colchicine products are sometimes formulated on a smaller scale by compounding pharmacies, often for use in the treatment of back pain. Three of the deaths from intravenous colchicine occurred in March and April of 2007 and were associated with the use of compounded colchicine that, due to an error in preparation, was eight times more potent than the amount stated on the label. The FDA has not approved colchicine in any dosage form for the treatment of back pain. In May 2007, the FDA informed all health care professionals about these deaths associated with compounded injectable colchicine products. The FDA's policy on pharmacy compounding is stated in a CPG on pharmacy compounding.
This action does not affect colchicine products that are dispensed in tablet form and are frequently used to prevent gout attacks.