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Gout is a type of arthritis which affects joints making them swollen and sore. Attacks of the condition can occur due to a buildup of uric acid, also known as urate. As part of its Unapproved Drugs Initiative designed to remove unapproved drugs from the market by means of a “risk-based enforcement program” that concentrates on products that “pose the highest threat to public health and without imposing undue burdens on consumers, or unnecessarily disrupting the market,” the FDA in September 2010 ordered a halt to the manufacture, distribution, and marketing of unapproved single-ingredient oral colchicine. These medications were and are widely used for the daily prevention of gout and to treat acute gout flare-ups and Familial Mediterranean Fever. 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Without our safety review and proper drug labeling, the old standard of care would likely have continued, to the detriment of patients.” Noting that the unapproved colchicines medications had never been evaluated by the FDA and thus should not be viewed as generic drugs, which must be “approved by the FDA to assure that the approved generic drug products meet the same standards as the innovator drug,” Deborah M. Autor, director of CDER’s Office of Compliance, said “It is a priority for the FDA to get unapproved medications, such as older versions of single ingredient oral colchicine, either updated to conform to FDA’s current approval standards or off the market.” One source for FDA-approved colchicine for gout The only company manufacturing and marketing single-ingredient colchicine medications that applied for FDA approval and submitted its product to the rigorous testing and approval process was URL Pharma, maker of Colcrys. 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For the treatment of acute gout, the recommended dosage for adults is 1.2 mg taken at first sign of an attack followed by 0.6 mg one hour later. You can continue with an additional 0.6 doses every two to three hours, taking care never to exceed 1.8 mg per hour.