Uloric lawsuits continue to mount, with one of the most recent cases brought by a resident of Tennessee who suffered a heart attack several years after he began using the medication.
According to a complaint filed in the U.S. District Court, Northern District of Illinois, on April 15th, Timothy Dixon was prescribed Uloric (febuxostat) for gout – a painful form of arthritis caused by high uric acid levels – in 2011. He suffered a heart attack in April 2019, at which time he discontinued Uloric. (Case No.: 1:20-cv-02325)
Like other Uloric lawsuit plaintiffs, Dixon claims Takeda Pharmaceuticals had long known the drug could cause heart problems and other adverse events, but intentionally failed to include those concerns on the product’s warning label.
“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.”
Takeda Pharmaceuticals’ launch of Uloric was delayed by five years due to concerns surrounding potential heart side effects. When the U.S. Food & Drug Administration (FDA) finally did approve Uloric in 2009, the agency ordered the company to conduct a post-market study to better asses those risks.
Data from that clinical 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 findings suggested the risk of all-cause mortality and cardiovascular death were higher with Uloric compared to an older gout drug called allopurinol.
The study had involved more than 6,000 patients suffering from gout who were treated with either Uloric or allopurinol. Among the Uloric group, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year. By contrast, just 11 heart-related deaths occurred for every 1,000 patients prescribed allopurinol for a year. There were also 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol.
In February 2019, 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.