Despite being used for decades as a primary treatment for acute gout, optimal colchicine dosing has not been systematically evaluated. This is potentially important, as higher doses of colchicine can frequently be associated with the undesired consequence of severe diarrhea and gastrointestinal distress.
On February 19, 2009, the US Food and Drug Administration (FDA) approved the licensing of febuxostat for the treatment of hyperuricemia in patients with chronic gout. This is the only approved indication for the drug at this time. Febuxostat will be marketed under the trade name Uloric and is manufactured by Takeda Pharmaceuticals. Links to […]
Urate lowering therapy can be very effective for reducing flares of gout, thereby preventing ongoing joint damage and deformity. Despite this efficacy, most gout patients are undertreated, leading to undue painful flares and joint damage. Non-adherence to therapy is a strong contributor to undertreatment.
FDA Arthritis Drug Advisory Committee Recommends Approval of Febuxostat for Treatment of Hyperuricemia of Gout
At their November 24, 2008 meeting, the FDA Arthritis Drug Advisory Committee heard updated efficacy and safety data for febuxostat for the treatment of gout-associated hyperuricemia. The committee’s recommendation was carried on a vote of 12 to 0. Final FDA approval of the drug is pending; however, FDA approval generally follows the recommendations of the advisory committee.