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AZ's Gout Drug Gets FDA Go-Ahead With Safety Caveats

This article was originally published in Scrip

Executive Summary

The US FDA has approved AstraZeneca's Zurampic (lesinurad) to treat treat high levels of uric acid in the blood associated with gout. The approval, for its use in combination with a xanthine oxidase inhibitor (or XOI, such as allopurinol or febuxostat, which reduce uric acid production), is conditional upon AstraZeneca completing a postmarketing study to further evaluate the drug's renal and cardiovascular safety. Zurampic has a boxed warning about the raised risk of acute kidney failure when Zurampic is used without an XOI and with higher than approved doses.

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