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).
Approved vs. Unapproved Colcrys
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.
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