Lawsuits involving Uloric continue to mount in the wake of last year’s U.S. Food & Drug Administration (FDA) warning on the serious side effects potentially associated with Takeda Pharmaceutical’s popular gout treatment.
One of the latest Uloric lawsuits was filed the U.S. District Court, Northern District of Illinois, and alleges the medication was responsible for a North Carolina man’s heart attack. (Case No. 1:20-cv-01512)
According to the March 2nd complaint, Charles Watson began taking Uloric in December 2013, at which time Takeda Pharmaceuticals represented the medication as an appropriate and suitable treatment for gout. He suffered a heart attack less than four years later, in March 2017.
“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 lawsuit 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.”
Watson asserts the heart attack could have been avoided had Takeda Pharmaceuticals provided adequate safety warnings to patients and doctors.
The FDA approved Uloric (febuxostat) in 2009, following a five-year delay that reflected the agency’s concern over the drug’s potential cardiovascular side effects. As a condition of approval, however, Takeda Pharmaceuticals was required to conduct a post-market study to better evaluate those risks.
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.
Roughly a year later, the FDA directed Takeda to add a new Black Box Warning – the strongest possible safety notice – to the Uloric label and restricted its use to patients who aren’t able to tolerate or have had a poor response to allopurinol.