A Kentucky man who suffered a heart attack after taking Uloric for nearly two years claims Takeda Pharmaceuticals failed to adequately warn doctors and patients about the cardiovascular risks potentially associated with its popular gout medication.
According to a complaint filed in the U.S. District Court, Northern District of Illinois, on February 14th, Wade Tackett was prescribed Uloric in 2013. He experienced a heart attack in 2015. (Case No. 1:20-cv-01127)
Takeda received U.S. Food & Drug Administration (FDA) approval to market Uloric (febuxostat) for gout in 2009, after a five-year delay resulting from concerns over the drug’s possible heart risks. As a condition of approval, Takeda was required to conduct a post-market study to better evaluate Uloric’s cardiovascular side effects.
Data from that trial — The Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) – was finally published in the New England Journal of Medicine in March 2018. The study suggested the risk of all-cause mortality and cardiovascular death were higher with Uloric compared to an older gout drug called allopurinol.
The FDA ultimately ordered Takeda to add a new Black Box Warning – the strongest possible safety notice – to the Uloric label and restricted its use to patients who can’t tolerate or haven’t responded well to allopurinol.
Like other Uloric lawsuit plaintiffs, Tackett claims his heart attack was the direct result of his febuxostat use. He further asserts that Takeda was aware that Uloric could cause serious cardiovascular complications long before the FDA-mandated label update, but intentionally failed to notify the public of these risks.
“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,” the complaint states. “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.”
Because Takeda actively concealed the side effects associated with Uloric, Tackett asserts he and his doctors were unaware, and could not have reasonably known or have learned through normal due diligence, that taking febuxostat would increase his likelihood of suffering a heart attack. Tackett further claims that he never would have used Uloric had he and his physicians been provided with adequate safety warnings.