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Texas Man Blames Uloric for His Heart Attack

A Texas man recently filed a new Uloric lawsuit in the U.S. District Court for the Northern District of Illinois. He claims that after taking the gout medication, he suffered from serious injuries. He seeks to hold manufacturer Takeda Pharmaceuticals liable for damages.

In February 2019, the FDA required a boxed warning be placed on the Uloric (febuxostat) label—the highest level of warning a drug can carry. It alerts healthcare providers and patients to the possible increased risk of death from all causes with Uloric compared to allopurinol (Zyloprim), another prescription gout medication.

FDA Concerned About Uloric Cardiovascular Risks Early On

According to his complaint, the plaintiff started using Uloric in 2010, when his doctor prescribed it to treat his medically diagnosed gout. The defendants represented the drug to be appropriate and suitable for such purposes. Then, on June 2, 2018, the plaintiff experienced a cardiac arrest that required medical treatment. He blames his injury on his use of Uloric and states that both he and his doctors were unaware of the cardiovascular risks associated with the medication.

The U.S. Food and Drug Administration (FDA) approved Uloric (febuxostat) in 2009 as an alternative treatment for hyperuricemia, which is high levels of uric acid in the blood, and gout. At the time, allopurinol was the leading gout medication on the market and had been used since 1946 to treat the condition. Uloric was approved mainly as an alternative for patients who were not experiencing significant relief with allopurinol.

Both Uloric and allopurinol work by inhibiting the enzyme xanthine oxidase, which promotes the production of uric acid. By inhibiting the action of this enzyme, the medications lower the uric acid levels in the blood.

By the time the manufacturer received FDA approval for marketing Uloric in the U.S., it had been interacting with the FDA for nearly five years. The FDA had expressed concern about the cardiovascular risks associated with the drug and required the manufacturer to provide further data before granting approval.

When the FDA approved Uloric, it did so with a condition—Takeda had to conduct additional studies to assess the cardiovascular safety of the drug.

FDA Requires Black-Box Warning on Uloric

The post-marketing trial was called The Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) trial. Researchers compared febuxostat and allopurinol, looking at cardiovascular outcomes like cardiovascular death, nonfatal heart attack, nonfatal stroke, and unstable angina with urgent revascularization, as well as death from all causes.

Results showed that the overall rates of cardiovascular events were similar in both groups. Mortality rates, however, were higher in the febuxostat (Uloric) group than in the allopurinol group. The reason for these deaths was unclear.

Based on these findings, the FDA updated the Uloric prescribing information to require a boxed warning on the product label, as well as a new patient medication guide. The agency also limited the approved use of Uloric only to those patients who were not treated effectively with allopurinol, or who suffered difficult side effects with allopurinol.

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