FDA takes action on unapproved colchicine

The US Food and Drug Administration intends to take action against companies marketing unapproved injectable formulations of colchicine, a drug used to treat gout. The compound is highly toxic and 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 one that can result in serious health risks, including death.

The agency says it 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.

The FDA stated that individuals and companies must stop making these products within 30 days and stop shipping them 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.