The FDA recently added a new boxed warning to the prescribing information for febuxostat based on results from the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) trial. This trial was required by the FDA and was a randomized, double-blind trial comparing febuxostat to allopurinal in 6190 people with gout. The primary endpoint was a composite of major adverse cardiovascular events including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and unstable angina with urgent revascularization. While the agents were equivalent for the composite primary endpoint, there were significantly more cardiovascular deaths and deaths due to all cause mortality in the patients treated with febuxostat. In addition to the Black Box Warning, the FDA is now restricting the use of febuxostat to patients that failed or intolerant of allopurinol.
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