FDA Adds Boxed Warning for Febuxostat

February 22, 2019

Febuxostat was FDA-approved in 2009 to treat gout in adults.

Officials with the US Food and Drug Administration (FDA) are adding a Boxed Warning to the prescribing information for febuxostat (Uloric, Takeda) since, they noted, there may be an increased risk of cardiovascular (CV) death and all-cause mortality in patients treated with this gout drug their compared to another gout medicine, allopurinol. FDA officals are also limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol.

"This conclusion is based on our 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 Uloric," FDA officials noted in a statement on their website.

Febuxostat was FDA-approved in 2009 to treat gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Uloric works by lowering uric acid levels in the blood.

The number of medicines to treat gout is limited and there is an unmet need for treatments for this disease. Patients should advise health care professionals if they have a history of heart problems or stroke and discuss the benefits and risks of using Uloric to treat your gout. Patients should seek emergency medical attention right away if they experience the following symptoms while taking Uloric: chest pain; shortness of breath; rapid or irregular heartbeat; numbness or weakness on one side of the body; dizziness; trouble talking; sudden severe headache.