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14-03-2019 | Gout | News

approvalsWatch

FDA approves oral colchicine for gout flare prophylaxis

medwireNews: Oral colchicine has been approved by the US FDA for the prevention of flares in people with gout.

The agent will be available as a solution containing 0.6 mg colchicine per 5 mL and should be taken at a maximum recommended dose of 1.2 mg/day, without regard to meals.

Oral colchicine should not be given to patients with both renal and hepatic impairment, and individuals with one of these conditions should be monitored closely during treatment, warns the FDA. The label specifies that the drug should not be given in combination with agents that inhibit both CYP3A4 and P-glycoprotein in this population due to the possibility of life-threatening drug interactions.

The FDA also advises that oral colchicine treatment may lead to transient impairment of male fertility in rare cases.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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