FDA warns that febuxostat may increase risk of heart-related mortality

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In a clinical trial, patients with gout took either febuxostat or allopurinol.
In a clinical trial, patients with gout took either febuxostat or allopurinol.

The Food and Drug Administration (FDA) has issued a safety communication warning the public that preliminary results from a clinical trial assessing the safety of febuxostat (Uloric; Takeda) showed an increased risk of cardiovascular (CV)-related death compared to allopurinol.

The safety trial (n>6,000), which the FDA required Takeda to conduct when the medicine was approved in 2009, included patients with gout treated with either febuxostat or allopurinol. The primary outcome was a combination of heart-related death, non-fatal heart attack, non-fatal stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery. 

Initial data showed febuxostat did not increase the risk of these combined events versus allopurinol overall. But when the safety outcomes were evaluated separately, febuxostat use was associated with a higher risk of CV-related death and all-cause mortality. 

The labeling for febuxostat already includes a warning about CV events due to studies conduced before approval indicating an increased rate of CV-related problems (heart attack, stroke, CV-related deaths) in patients treated with febuxostat versus allopurinol. Once the final data from the safety study are received, the FDA plans to comprehensively evaluate and update the public with any new information. 

Febuxostat, a xanthine oxidase inhibitor, is currently approved for the chronic management of hyperuricemia in patients with gout. Healthcare professionals are recommended to consider this safety information when deciding to prescribe or maintain their patients on febuxostat.


  1. Uloric (febuxostat): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death [press release]. US Food & Drug Administration. Nov 17 2017. Accessible at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm585281.htm
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