Medication Monitor

Generic Name (Trade Name—Company)
February 22, 2019


(Uloric—Multiple manufacturers)
FDA adds boxed warning for increased risk of death with gout medication

FDA has concluded there is an increased risk of death with febuxostat compared with another gout medicine, allopurinol. This conclusion is based on an in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with febuxostat, according to the agency.

As a result, FDA is updating the febuxostat prescribing information to require a boxed warning and a new patient Medication Guide. The agency is also limiting the approved use of febuxostat to certain patients who are not treated effectively or who experience severe adverse effects with allopurinol.

Advise patients to tell their doctor if they have a history of heart problems or stroke, to discuss the benefits and risks of using febuxostat to treat their gout, and to seek emergency medical attention right away if they experience chest pain, shortness of breath, rapid or irregular heartbeat, numbness or weakness on one side of the body, dizziness, trouble talking, or sudden severe headache while taking the medication.

Patients should not stop taking febuxostat without first talking to their doctor, as doing so can worsen their gout.

Health professionals should reserve febuxostat for use in patients who have experienced treatment failure with or do not tolerate allopurinol. Counsel patients about febuxostat's cardiovascular risk, and advise them to seek medical attention immediately if they experience the symptoms listed above.

See the FDA news release for more information.