FDA cracks down on marketing of injectable colchicine

JB Editor
  • Colchicine injections are an accepted, but not FDA-approved method to relieve acute gout symptoms.


    Colchicine reduces the swelling and pain caused by attacks of gout or gouty arthritis. Arthritis may trigger the deposit of uric acid crystals in joints, the main cause of gout, according to a report in Annals of the Rheumatic Diseases. The drug is usually taken as a tablet by mouth.


    But the FDA condemns the practice of injecting the drug: 


    "Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously," the FDA wrote in its release. "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."

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    The FDA said that "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."


    Click here to read the entire release from the FDA 


    Injectable colchicine was blamed for at least two deaths late in 2007


    If you know anyone (or if you yourself) have been using this remedy, take heed to the FDA's warning and its promise to crack down on manufacturers. You should also talk to your doctor right away for approved means of managing your condition. 

Published On: February 07, 2008