While the drug will remain on the market, the FDA has required that febuxostat bear a boxed warning and medication guide detailing the risks.

Febuxostat was approved 10 years ago, and at that time, FDA had expressed concern regarding its cardiovascular side effect profile.  It asked Takeda Pharmaceuticals, maker of febuxostat, to conduct a clinical trial to further examine the safety of the drug.  The CARES (Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities) trial began in April 2010 and concluded in June 2017, studying 6190 North American people with gout treated with febuxostat or allopurinol.  The primary outcome measure was a composite of cardiovascular death, nonfatal stroke or MI and unstable angina requiring urgent revascularization; the secondary outcome was all-cause mortality.  Febuxostat resulted in a cardiovascular death rate of 15 per 1000 patient years compared with 11 cardiovascular deaths per 1000 patient years with allopurinol.  Febuxostat also resulted in an all-cause mortality rate of 26 per 1000 patient years versus 22 per 1000 patient years with allopurinol. 

Prescribers are reminded to reserve febuxostat for use only in patients who cannot tolerate allopurinol or for those whose gout is refractory to allopurinol.

Patients should be educated regarding the known cardiovascular risks of febuxostat, and warned to seek urgent medical attention for symptoms of stroke or myocardial infarction.

Reference: 
Food and Drug Administration.  Drug Safety Announcement:  FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat).  February 21, 2019.