The U.S. Food and Drug Administration (FDA) has ordered companies to stop marketing unapproved drug products that contain colchicines in an injectable dosage form.
This action was taken because products containing colchicine for intravenous use have been marketed without approval. The FDA is making an effort to ensure that all drugs marketed in the United States have the required FDA approval and are safe, effective, of good quality, and appropriately labeled.
Colchicine is most commonly used for the treatment of gout. Colchicine for injection has been available in the United States since the 1950s and is administered intravenously for the treatment of acute gout attack.
There is an increased likelihood of colchicine toxicity when the drug is administered intravenously. In addition, serious safety concerns associated with the use of intravenous colchicines drugs have caused reports to be made to the FDA.
The FDA states that, “among the commonly reported events were neutropenia (low number of white blood cells), acute renal (kidney) failure, thrombocytopenia (low number of platelets), congestive heart failure, and pancytopenia (low number of all types of blood cells). Many of these adverse events are caused by colchicine toxicity, which can have serious and potentially fatal consequences.”
This action by the FDA does not affect colchicine tablets. For additional information, visit the FDA Web site at www.fda.gov or contact Antanya Chung, CCP, CPC, at (404) 633-3777.