FDA Issues Safety Alert for Gout Medication
Febuxostat may increase the risk for heart-related death.
In a safety announcement released Wednesday, the FDA warns of an increased risk for heart-related death with febuxostat (Uloric) compared with allopurinol for the treatment of gout.
The new findings are preliminary results from a safety study conducted by the drug manufacturer, Takeda Pharmaceuticals, at the request of FDA following pre-approval trials showing similar results. The latest clinical trial involved more than 6000 gout patients treated with febuxostat or allopurinol. The primary endpoint was a composite of heart-related death, non-fatal heart attack and stroke, and unstable angina with urgent coronary revascularization. Although febuxostat did not increase the risk for the composite outcome compared with allopurinol, febuxostat showed an increased risk for heart-related and all-cause mortality.
The current drug label for febuxostat (Uloric) already cautions clinicians and patients about increased risk for cardiovascular events, including heart attacks, strokes, and heart-related deaths. Clinicians should consider these risks when prescribing or continuing patients on the drug.
Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death. FDA, November 15, 2017 [news release].