FDA Curtails Marketing of Unapproved Injectable Colchicine

US Pharm. 2008;33(3):84.

The FDA said that it would take enforcement action against companies marketing unapproved injectable colchicine, used to treat gout. Colchicine is a highly toxic drug, especially when given intravenously, and the FDA is aware of 50 reports of adverse events connected to intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure.

"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." This action does not affect colchicine products that are dispensed in tablet form and are often used to prevent gout attacks.

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