FDA Cracks Down on Injectable Colchicine Following 23 DeathsFeb 7, 2008 | Parker Waichman LLP
Injected colchicine has never been approved by the Food & Drug Administration (FDA), and can be extremely toxic, the agency has warned. According to the FDA, 23 people have died as a result colchicines injections. Now the FDA is cracking down on the marketers of unapproved injectable colchicine.
Colchicine is a medication for acute gout. Approved oral forms of colchicine are sold by generic drug makers Watson Laboratories and Ivax, a unit of Teva Pharmaceutical Industries of Israel. The FDA crackdown on unapproved injectable colchicines does not affect these approved medications.
In spite of its approved uses, colchicine is a highly toxic drug that 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 dose that can result in serious health risks, including death. The FDA said it's aware of 50 adverse events associated with the use of intravenous colchicine, including the 23 deaths. Among the common adverse events reported to the FDA 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).
In addition to being manufactured by pharmaceutical companies, the FDA said injectable colchicine products are sometimes formulated on a smaller scale 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 form for the treatment of back pain.
The FDA said yesterday that Individuals and companies must stop making injectable colchicine 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.
"Today's action supports our ongoing efforts to end the marketing of unapproved drugs with serious health risks," said Janet Woodcock, M.D., the FDA deputy commissioner for scientific and medical programs, said in a press release. "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 June 2006, the FDA began taking action against marketed unapproved drugs. That effort seeks to ensure that all drug products marketed in the United States are shown, through the drug approval process, to be safe and effective and to meet appropriate standards for manufacturing and labeling. The agency published a Compliance Policy Guide (CPG) in June 2006 that describes the FDA's risk-based enforcement approach to marketed unapproved drugs. This crackdown on unapproved injectable colchicine represents the seventh action taken by the agency against companies that market and sell unapproved drugs since issuing its CPG.