FDA takes first step to stop the marketing of unapproved gout injections

WASHINGTON The Food and Drug Administration is taking action to stop companies from marketing unapproved injectable colchicines, a drug used to treat gout. This follows the compliation of 50 reports of adverse events associated with the intravenous version of the drug, which includes 23 deaths. Other side 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, FDA deputy commissioner for scientific and medical programs, chief medical officer and acting director of the Center for Drug Evaluation and Research. “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.”

In addition to being manufactured by pharmaceutical companies, injectable colchicine products are sometimes formulated 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 for the treatment of back pain.

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.