The FDA has required a black box warning on uloric (febuxostat), finding that the gout treatment poses an increased risk of heart-related death compared to other gout treatment.
Febuxostat is an FDA-approved medication for the treatment of gout. Gout is a type of arthritis that occurs when uric acid builds up in the body, causing sudden attacks of redness, swelling, and pain in one or more joints. Febuxostat works by lowering uric acid levels in the bloodstream. Uloric is a brand name for febuxostat.
Uloric drug labels already carry a Warning and Precaution concerning cardiovascular events, because the clinical trials conducted before approval of the drug showed a higher rate of heart-related problems in patients treated with Uloric, as compared to another gout medication, allopurinol. These problems included heart attacks, strokes, and heart-related deaths.
As a result, the U.S. Food and Drug Administration (“FDA”) required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct a safety study when the FDA approved the medicine back in 2009. That safety trial was conducted in over 6,000 patients with gout, who were treated with either Uloric or allopurinol. The study found that Uloric showed an increased risk of heart-related deaths and death from all causes, leading to a November 15, 2017, Drug Safety Communication by the FDA.
Thereafter, the FDA performed an in-depth review of the results from that safety clinical trial and concluded that there was an increased risk of heart-related death and death from all causes with Uloric. On February 21, 2019, the FDA required Takeda to update the Uloric labeling with a Black Box Warning (the most prominent type of warning), and limited the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol.
The FDA has advised that 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 your body
- Trouble talking
- Sudden severe headache
The FDA further advised patients: Do not stop taking Uloric without first talking to your health care professional, as doing so can worsen your gout.