The FDA has added a black box warning on uloric (febuxostat), finding that the gout treatment poses an increased risk of heart-related death compared to other gout treatment.

Febuxostat is an FDA-approved medication for the treatment of gout. Gout is a type of arthritis that occurs when uric acid builds up in the body, causing sudden attacks of redness, swelling, and pain in one or more joints. Febuxostat works by lowering uric acid levels in the bloodstream. Uloric is a brand name for febuxostat.

Uloric drug labels already carry a Warning and Precaution concerning cardiovascular events, because the clinical trials conducted before approval of the drug showed a higher rate of heart-related problems in patients treated with Uloric, as compared to another gout medication, allopurinol. These problems included heart attacks, strokes, and heart-related deaths.


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