FDA Alert: Febuxostat May Increase Risk of Heart-Related Adverse Events, Death

Gout medication febuxostat (Uloric) was associated with an increased risk of heart-related death and death from all causes.

The US Food & Drug Administration (FDA) has released an alert following preliminary results from a safety clinical trial of the gout medication febuxostat (Uloric®) that showed an increased risk for heart-related death compared with allopurinol.

The FDA required Uloric’s manufacturer, Takeda Pharmaceuticals, to conduct this safety trial when the drug was approved in 2009 because of a higher rate of heart-related problems, including heart attacks, stroke, and heart-related deaths, in patients treated with febuxostat compared with allopurinol. This trial was completed recently, and the FDA will conduct a comprehensive review and update the public with new information once final results from Takeda Pharmaceuticals are received. The febuxostat drug label already carries a Warning and Precaution about cardiovascular events.

The safety trial examined more than 6000 people with gout who were treated with either febuxostat or allopurinol. The primary outcomes included heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery.

Preliminary results show that febuxostat did not increase the risk for these combined events compared with allopurinol. However, when the outcomes were evaluated separately, febuxostat was associated with an increased risk for heart-related death and death from all causes.

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The FDA notes that healthcare professionals should consider this safety information when determining whether to prescribe or continue patients on febuxostat.

Clinicians and patients are encouraged to report adverse events or side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


US Food and Drug Administration. FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric). 
https://www.fda.gov/downloads/Drugs/DrugSafety/UCM584803.pdf. Published November 15, 2017. Accessed November 16, 2017.