Available only by prescription, Colcrys is an FDA-approved medicine used to treat gout and familial Mediterranean fever. The product is thought to work by limiting the activity of certain inflammatory cells (neutrophils) in the body. This medication comes in tablet form and is generally taken once or twice a day. Most people tolerate it well, but common side effects include diarrhea and nausea.
What Is Colcrys?
Colcrys® (colchicine) is a prescription medication approved for both preventing and treating gout attacks and for treating familial Mediterranean fever (FMF). Colcrys is the only colchicine medication approved by the U.S. Food and Drug Administration (FDA).
Colchicine was previously available in pharmacies as a medication that was never approved by the 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, these older colchicine products are not regulated by the FDA. Many patients (and even healthcare providers) are surprised to learn that most colchicine products are unapproved.
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 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 Colcrys product on the market (combination colchicine and probenecid products have been approved for quite some time).
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.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed May 27, 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 15, 2010.
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