Uloric (febuxostat) is indicated for the chronic management of hyperuricemia in patients with gout. Gout is a form of arthritis, and occurs when uric acid in the body builds up and causes sudden attacks of redness, swelling, and pain in one or more joints.
Uloric is considered a xanthine oxidase (XO) inhibitor, and eases gout symptoms by lowering uric acid levels in the blood.
When Uloric was approved by the US Food and Drug Administration (FDA) in 2009, its manufacturer, Takeda Pharmaceuticals, was required to conduct a safety study. The study was titled “Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Comorbidities” (CARES). This trial recently concluded, but the FDA has yet to complete their comprehensive review of the study results.
On November 15 2017, the FDA issued a drug safety communication concerning Uloric based on the preliminary findings of the study. In this document, they warned of an increased risk of heart-related death with Uloric compared to other gout medications that contain allopurinol.
In addition, they provide the following information:
The primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery. The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.
At this stage, the mechanism of harm is not clearly understood. Otherwise put, researchers are unsure how exactly Uloric is causing death in patients who use it.
The current drug label for Uloric warns that when compared to similar gout drugs that contain allopurinol, Uloric has a higher rate of cardiovascular thromboembolic events such as cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes. However, they are quick to point out that no causal relationship has yet been established.
Going forward, the FDA is considering adding increased warnings to the drug label for Uloric in order to more adequately convey the risk of cardiac-related deaths. According to a recent MedScape article, “Options include a new warning in the labeling in addition to the one already there, or pulling [Uloric (febuxostat)] from the market.” The article also mentions several doctors who are not in favor of removing Uloric from the market, given its advantages over allopurinol in certain populations.
We will continue to monitor the medical and regulatory literature for more information on the association between Uloric and fatal cardiovascular events, and report on significant developments.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
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