FDA Approves Zurampic for the Treatment of Gout

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FDA Approves Zurampic for the Treatment of Gout
FDA Approves Zurampic for the Treatment of Gout

WEDNESDAY, Dec. 23, 2015 (HealthDay News) -- Zurampic (lesinurad) has been approved by the U.S. Food and Drug Administration to control blood levels of uric acid associated with gout.

Zurampic, approved for use in combination with xanthine oxidase, helps the kidneys avoid reabsorbing uric acid, then aids the kidneys in excreting uric acid from the body, the FDA said in a news release.

Zurampic was evaluated in clinical studies involving 1,537 people. Those treated with the drug combination saw a drop in uric acid levels, compared to those who took placebos. The most common side effects of Zurampic included headache, increased blood creatinine, influenza, and gastroesophageal reflux disease.

Zurampic's label will include a boxed warning of the possibility of kidney failure if it is used without the second drug, or at higher-than-approved doses, the FDA said. The agency also stated that it ordered Zurampic's Delaware-based manufacturer AstraZeneca to conduct additional trials to further evaluate the drug's effects on the kidneys and heart.

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