FDA takes action against unapproved injectable colchicine products

The FDA is taking action against manufacturers marketing unapproved injectable colchicine products due to serious health risks associated with their use. Often used to treat gout, injectable colchicine has a narrow margin between the effective dose and toxic dose that can result in potentially fatal effects including low blood cell counts, cardiac events, and organ failure. The FDA is aware of 50 reports of adverse events, including 23 deaths. This action does not affect colchicine tablet formulations.

Companies and individuals must stop making these products within 30 days and stop shipping the product within 180 days or face regulatory action. After that time, all injectable colchicine must have FDA approval to be manufactured or shipped interstate.

For more information visit http://www.fda.gov/cder/drug/unapproved_drugs/colchicine_qa.htm.