The U.S. Food and Drug Administration (FDA) has issued a boxed warning for febuxostat after a safety study found an increased risk of heart-related death, as well as death from all causes, with febuxostat. The agency has also approved colchicine as an oral solution for prophylaxis of gout flares in adults.
Safety Risk with Febuxostat
The FDA is alerting healthcare providers and patients about the risk of death associated with the use of febuxostat (Uloric), which was approved in 2009 to treat adults with gout. A clinical safety trial found an increased risk of heart-related death, as well as death from all causes, with febuxostat. This finding is a higher risk of death compared with allopurinol.1
The FDA is updating the treatment’s prescribing information to require a boxed warning.
Healthcare professionals should reserve the use of febuxostat for cases in which allopurinol fails to work and for patients who can’t tolerate allopurinol. Patients should be counseled about the cardiovascular risks of using febuxostat. Advise them to seek medical attention immediately if they experience any of the following symptoms: chest pain, shortness of breath, rapid or irregular heartbeat, numbness or weakness on one side of the body, dizziness, trouble talking and/or sudden severe headache.