The Uloric lawsuit claims the manufacturer of Uloric failed to warn users of the increased risk of heart attacks and strokes.
What Do We Know About the Uloric Lawsuits
Uloric (Febuxostat) is a xanthine oxidase inhibitor prescribed for the management of chronic hyperuricemia (excess uric acid) in adult patients with gout. Uloric was brought to market by Takeda Pharmaceuticals and originally received FDA approval on February 13, 2009.
When the Food and Drug Administration (FDA) approved Uloric in 2009, the government required a warning about cardiovascular events and also required that Takeda conduct a mandatory post-marketing cardiovascular safety study.
The results of the 6,000-patient safety trial were published in the New England Journal of Medicine on March 12, 2018. The authors of the study found a statistically significant increased risk of cardiovascular death for users of Uloric compared to users of allopurinol.
In February of 2019, the FDA required the manufacturer of Uloric to begin placing warnings on its drug discussing the link between Uloric and cardiovascular problems.
What Do We Know About Gout
Gout is a form of arthritis characterized by sudden, severe attacks of pain, swelling, redness, and tenderness in the joints, often in the feet and toes, which results from elevated uric acid levels in the bloodstream.
There is an elevated risk of cardiovascular events in patients with hyperuricemia and gout which is not entirely understood but may be related to chronic inflammation associated with the underlying disease process. Gout patients also typically suffer from various comorbidities which are themselves associated with an increased risk for cardiovascular events.
Gout is a disease state for which only a few medical therapies are available and allopurinol has long been the standard of treatment. Originally brought to market by Casper Pharma LLC in 1966, allopurinol has an established safety profile and has been available in generic form since at least September 1984.
Only patients with severe renal dysfunction or those who cannot tolerate allopurinol should try Uloric, considering allopurinol is just as efficacious as Uloric and is dramatically cheaper.
FDA and Scientific Studies Regarding Uloric
On November 15, 2017, the Food and Drug Administration (FDA) issued a Drug Safety Communication alerting “the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol” and noted it would be conducting a comprehensive review of Uloric’s safety.
The FDA held a joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee on January 11, 2019, during which the safety of Uloric was discussed. While the committee agreed that biological plausibility for cardiovascular death was unclear, they “agreed that there is a consistent signal of cardiovascular death associated with febuxostat”.
Most committee members agreed that Uloric should no longer be designated as a first-line therapy for gout and should be reserved for patients who cannot tolerate allopurinol or where allopurinol was not effective. They also noted that Uloric should not be used in the general gout population or in patients with a history of cardiovascular events or at high risk for cardiovascular events.
The FDA issued another Drug Safety Communication on February 21, 2019, in which it stated there was an increased risk of death with Uloric compared to allopurinol. Thus, the FDA required the addition of a boxed warning for cardiovascular death and a Limitation of Use reserving treatment only for patients with symptomatic hyperuricemia.