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FDA Adds Boxed Warning To Gout Drug Uloric

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The FDA has added Boxed Warning to the label of gout medicine Uloric that highlights the increased risk of death with the drug.

Following an in-depth review of results from a safety clinical trial, the FDA has found that there is an increased risk of heart-related death and death from all causes with Uloric. Besides adding the Boxed Warning, the FDA is limiting the approved use of Uloric only to patients who have failed or do not tolerate another gout medicine Allopurinol.

Uloric, indicated for the chronic management of hyperuricemia in patients with gout, and developed by Takeda, was approved by the FDA in 2009.

The results of the FDA-mandated postmarketing study, published in The New England Journal of Medicine online, in March 2018, revealed that the "treatment with Uloric resulted in overall rates of major cardiovascular events that were similar to those associated with Allopurinol treatment among patients with gout who had coexisting cardiovascular disease. However, cardiovascular death and deaths from any cause were more frequent in the Uloric group than in the Allopurinol group".

Last June, a citizen petition was filed with the FDA requesting the immediate withdrawal of Uloric from the market.

Uloric is expected to go generic in June 2019, according to reports.

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