FDA Orders Black Box Warning for Uloric, a Medicine for Treating Gout

The U.S. Food and Drug Administration has just added a Black Box Warning for Uloric, Takeda’s popular medication for the treatment of gout. The agency issued a press release after concluding that the drug, also known as Febuxostat, carries an overall increased of death when compared to allopurinol, the other medication widely prescribed for the treatment of the chronic condition.

Uloric first received approval for the treatment of gout from the FDA in 2009. Gout is a painful form of arthritis caused by the accumulation of uric acid, leading to swelling, redness and inflammation in the joints.

At the time it received approval, Uloric was acknowledged as effective at lowering levels of uric acid in the bloodstream, but that approval was tempered by clinical trial observations that the drug was linked to an increased rate of cardiovascular events among those taking it.


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As a result, the drug manufacturer was required to pursue additional safety clinical trials following 6,000 gout patients prescribed either Uloric or allopurinol. The new warning comes following a thorough evaluation of those test results.

Uloric Death Rates Determined To Be Higher Than Allopurinol

Though the initial analysis of the results of the postmarket clinical testing indicated parity of adverse effects between allopurinol and Uloric, closer scrutiny revealed that Uloric delivered a higher number of deaths from heart-related causes than was true for allopurinol, with 15 Uloric deaths per year out of 1,000 patients taking it compared to 11 out of 1,000 deaths per year among those taking allopurinol.

A similar differential was found for deaths from any cause per 1,000 patients treated, with 26 Uloric deaths compared to 22 allopurinol patients.

The explanatory statement issued by the Food and Drug Administration’s safety communication read in part, “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,” and went on to say “We are also limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol.”

If you or someone you love was prescribed and tool Uloric and suffered heart-related death, a non-deadly stroke or heart attack, or a condition called unstable angina caused by the inadequate blood supply to the heart, you may be eligible for compensation for the damages that you suffered. Contact us today to speak to an experienced attorney about your situation.

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