Medication Monitor

Generic Name (Trade Name—Company)
January 4, 2016


New agent treats high blood uric acid levels associated with gout

FDA approved lesinurad to treat hyperuricemia associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI).

Lesinurad works by helping the kidney excrete uric acid. It does this by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney.

Safety and efficacy for lesinurad were evaluated in three randomized, placebo-controlled studies in combination with a XOI involving 1,537 participants for up to 12 months. Participants treated with lesinurad in combination with a XOI experienced reduced serum uric acid levels compared with those on placebo.

The most common adverse reactions in clinical trials were headache, influenza, increased blood creatinine, and gastroesophageal reflux disease.

Lesinurad has a boxed warning that provides important safety information for health professionals, including the risk for acute kidney failure, which is more common when used without an XOI and with higher than approved doses of lesinurad.

FDA is also requiring a postmarketing study to further evaluate the renal and cardiovascular safety of lesinurad.