People treated with the gout drug febuxostat, known by the brand name Uloric, are at an increased risk of death compared to those taking the gout medicine allopurinol, the Food and Drug Administration (FDA) cautioned in a safety communication. The agency is requiring a boxed warning – its most serious warning – be added to the safety label of febuxostat based on a review of a large, post-market safety study.
“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,” the FDA said in a safety communication.
Uloric was approved by the FDA in 2009 to treat adults with a type of arthritis called gout. Gout occurs when uric acid builds up in the body and causes sudden attacks of redness, swelling and pain in one or more joints. There are only a limited number of medications to treat gout. Uloric’s black box warning recommends that the drug be reserved for patients who cannot tolerate or have not had success with allopurinol.
Patients should be counseled about their cardiovascular health before being prescribed Uloric. Those treated with Uloric should seek immediate medical attention 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.
In November 2017, preliminary results from a clinical trial showed patients taking Uloric were at greater risk of heart-related death than patients treated with allopurinol. The agency ordered Uloric’s maker, Takeda Pharmaceuticals, to conduct a safety study to better understand the risks. The medication already carried warnings about cardiovascular events based on clinical trials before the medication was approved. These events included heart attacks, strokes and heart-related deaths.
FDA Safety Alert