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The FDA has issued a to alert patients and clinicians of an increased risk of heart-related death among patients with gout receiving the urate-lowering agent febuxostat (Uloric) compared with those given allopurinol.
That finding emerged from a safety study of more than 6,000 patients that was mandated by the FDA when the drug was approved in 2009. Febuxostat's labeling already has a warning and a precaution about cardiovascular events, because in preapproval clinical trials, there was a higher rate of heart attacks, strokes, and heart-related deaths than with allopurinol.
The primary outcome in the postmarketing safety study was a combination of cardiac-related death, nonfatal heart attack or stroke, or cardiac ischemia requiring urgent surgery.
Preliminary analysis of data from that study indicated that there was no overall increased risk of the combined events with febuxostat compared with allopurinol, but when the individual outcomes were analyzed separately, an increased risk was seen for febuxostat in heart-related death and all-cause mortality. No numerical details were included in the FDA's communication, however.
In its announcement, the FDA noted that "healthcare professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat," and that patients should discuss any concerns with their providers.
When the final results of the safety study are received from the manufacturer, Takeda Pharmaceuticals, the FDA plans to conduct a full review of the data and will issue an update.