A recent Uloric lawsuit claims that Takeda knew that the gout drug Uloric was associated with adverse cardiovascular events but didn’t warn consumers.

Plaintiff Peter K. argues that Takeda Pharmaceuticals received adverse event reports about their gout medication but failed to share the information with the public and the U.S. Food and Drug Administration (FDA).

Uloric (febuxostat) is a medication used to treat gout, a form of arthritis associated with too much uric acid in the body. Although uric acid is a natural byproduct of cellular processes, too much uric acid being produced or a failure of the kidneys to filter out the substance can cause gout.

When a person has gout, uric acid builds up in the joints where it forms needle-like crystals. These crystals then irritate the tissues in joints and cause swelling and pain. Uloric aims to treat gout by reducing the amount of uric acid found in the body.

In February 2019, however, the FDA released an update that Uloric was associated with an increased risk of heart-related death. The update was based on results from an FDA mandated study done by Takeda.

CARES Study

The Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) trial reportedly showed that Uloric was associated with a “significant increase in cardiovascular death” when compared to allopurinol, another gout medication. Uloric patients were reportedly also more likely to die in general, a statistic reportedly driven by the cardiovascular death rates.

As a result of study outcomes, the FDA required a new black box warning on the Uloric label. Additionally, the FDA limited the approved use of the drug only to patients who were not treated effectively by allopurinol or who had severe side effects while on the alternative gout medication.

Although the FDA took action to warn consumers and doctors of the risks, Peter’s recent Uloric heart lawsuit claims that Takeda knew or should have known about the drug’s risks sooner and should have warned the public.

Uloric Lawsuit Claims

Peter claims that he was not sufficiently warned of the risks associated with Uloric before using the drug to treat his gout. In 2016, after taking Uloric, Peter allegedly suffered from a heart attack that he claims was directly caused by the gout drug.

The Uloric complaint also claims that manufacturer Takeda ignored reports of adverse events associated with their gout medication, even when these reports involved “severe and debilitating injuries.” Peter argues that the company concealed the risks from consumers and even submitted false reports to the FDA in order to convince consumers that the drug was safe.

“Rather than doing adequate testing to determine the cause of these injuries or rule out Uloric’s design as the cause of the injuries, defendants continued to market Uloric as a safer and more effective prescriptive drug as compared to other available alternative treatment for hyperuricemia and gout,” the Uloric lawsuit claims.

Peter’s Uloric Lawsuit is Case No. 1:19-cv-07060 in the U.S. District Court for the Northern District of Illinois.