A newly filed Uloric lawsuit claims Takeda Pharmaceuticals intentionally concealed the significant cardiovascular risks associated with its gout drug.
According to a complaint filed yesterday in Illinois federal court, Peter Gust Kandis was taking Uloric when he suffered a heart attack in 2016. Kandis asserts that Takeda knew the gout medication was associated with major cardiovascular risks, yet endeavored to conceal that information from the public and submitted false reports to the U.S. Food & Drug Administration (FDA).
Takeda won FDA approval to market Uloric (febuxostat) in 2009, following a five-year delay that allegedly reflected concern over potential heart side effects. Upon approval, the agency directed Takeda to conduct a post-market study to better gauge Uloric’s cardiovascular risks.
The results of Takeda’s post-market trial were published in the New England Journal of Medicine in March 2018, and suggested that the risk of all-cause mortality and cardiovascular death were higher with febuxostat compared to an older gout drug called allopurinol. Because of these findings, the FDA ordered Takeda to add a new Black Box Warning – the most urgent safety notice – to the Uloric label in February 2019. The agency also relegated Uloric to second-line status, limiting its use to gout patients who can’t tolerate or haven’t responded well to another gout drug called allopurinol.
However, Kandis and other Uloric lawsuit plaintiffs claim that Takeda could have acted earlier to warn patients and doctors.
“Defendants ignored reports from patients and health care providers throughout the United States of Uloric’s failure to perform as intended, which led to the severe and debilitating injuries suffered by Plaintiff, and numerous other patients,” their complaints state.
Because Takeda failed to update the Uloric label on its own and continued to market the medication as a superior alternative to allopurinol, patients and their doctors remained oblivious to alleged defects or the significant dangers associated with the gout drug.
“As a direct and proximate result of one or more of the above-stated negligent acts by Defendants, Plaintiff suffered grievous bodily injuries and consequent economic and other losses, including pain and suffering, loss of a normal life, medical expenses, lost income and disability,” their Uloric lawsuits conclude.