FDA adds boxed warning for febuxostat

US Food and Drug Administration (FDA) officials add a boxed warning to prescribing information for febuxostat (Uloric, Takeda) because, they noted, there may be an increased risk of cardiovascular death patients treated with this drug against gout, compared with another drug against gout, allopurinol. FDA officials also limit the approved use of Uloric to certain patients who are not treated effectively or who experience serious side effects with allopurinol.

"This conclusion is based on our extensive review of the results of a safety clinical trial that revealed an increased risk of cardiac death and death from all causes with Uloric," officials said. of the FDA in a statement posted on their website.

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

The number of drugs to treat gout is limited and there is an unmet need for treatments for this disease. Patients should inform health care professionals if they have a history of heart problems or stroke and discuss the benefits and risks badociated with using Uloric to treat your condition. drop. Patients should immediately seek emergency medical attention if they experience the following symptoms while taking Uloric: chest pain; shortness of breath; fast or irregular heartbeat; numbness or weakness of one side of the body; dizziness; difficulty speaking suddenly severe headache.