FAST: new look at the febuxostat safety profile

Febuxostat is a urate-lowering drug that was approved for the management of gout by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) more than 10 years ago. It is a non-purine xanthine oxidase inhibitor, particularly useful in patients who are refractory or intolerant to allopurinol, and requires no dose limitation in chronic kidney disease of stages 1–3. Despite filling an important therapeutic gap, febuxostat was not readily approved because pivotal trials had shown a nominal increase in cardiovascular deaths on febuxostat (80 or 120 mg/day) compared with allopurinol.