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The agency said its in-depth review of results from a safety clinical trial found that Uloric was associated with an increased risk of heart-related death and death from all causes.
Due to these findings, the FDA said it’s updating Uloric prescribing information to require a Boxed Warning — the most prominent warning — and a new patient Medication Guide.
The agency is also limiting the use of Uloric to certain patients who are do not get effective results or suffer severe side effects when taking allopurinol.
The FDA approved Uloric in 2009 to treat adults with gout, a chronic disease that affects about 8.3 million U.S. adults. Only a few medicines are available to treat gout.
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