Colchicine is a drug that is typically taken once or twice a day to treat gout flares or prevent gout attacks. Because this is an older medication, many colchicine products are unapproved and are not regulated by the FDA. Before using this medicine, let your healthcare provider know if you have any health conditions, such as liver or kidney problems.
What Is Colchicine?
Colchicine (Colcrys®) is a prescription medication most commonly used for the treatment of gout. It is useful for both treating gout flares and for preventing gout attacks.
Colchicine was previously available in pharmacies as a medication that was never approved by the United States Food and Drug Administration (FDA). As with many older medications, it was "grandfathered" into the current system without needing to undergo the rigorous studies that are now required. Consequently, most colchicine products were unapproved and were not regulated by the FDA.
Unapproved prescription drugs are relatively common. The FDA has begun to try to identify these drugs and fix the situation by offering manufacturers a period of exclusivity (like a brand-new drug would receive) in exchange for the manufacturers completing studies and completing new drug applications (both of which are costly endeavors).
In 2009, one company completed this process and received FDA approval for their colchicine product (Colcrys). At this time, Colcrys is the only FDA-approved, single-ingredient colchicine product on the market (combination colchicine and probenecid products have been approved for quite some time).
Colcrys is approved for treating and preventing gout and for treating familial Mediterranean fever (FMF).
In September 2010, the FDA ordered manufacturers of unapproved colchicine products to stop making and selling their products.
Food and Drug Administration, Center for Drug Evaluation and Research. FDA orders halt to marketing of unapproved single-ingredient oral colchicine (9/30/2010). FDA Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm227796.htm. Accessed October 8, 2010.
Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. 8th ed. Philadelphia (PA): Lippincott Williams & Wilkins;2008.
National Library of Medicine (US). Drugs and Lactation Database (LactMED). NLM Web site. Available at: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT. Accessed April 14, 2010.
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