Takeda Pharmaceuticals is facing yet another lawsuit over Uloric, a gout drug allegedly linked to an increased risk of heart attack and cardiovascular death.
This new case was filed in the U.S. District Court, Northern District of Illinois, on behalf of a man from Washington state who began taking Uloric for gout in 2015. He suffered a heart attack in April 2017. (Case No.: 1:20-cv-01944)
“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.”
The Uloric lawsuit further claims that Takeda concealed the medication’s risks and failed to provide the public with timely and adequate safety warnings, leaving the plaintiff and his doctors unaware that treatment could lead to a heart attack and cardiovascular death. Had appropriate warnings been provided, he would not have been prescribed Uloric and could have avoided his injuries.
Takeda received U.S. Food & Drug Administration (FDA) approval to market Uloric in 2009, following a 5-year delay because of concerns surrounding possible heart side effects. When the agency finally did approve the medication, Takeda was required to conduct a post-market study to better assess 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.
In February 2018, 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.
Uloric patients should tell their health care professional if they have a history of heart problems or stroke and discuss the benefits and risks of using the medication to treat gout. Those taking Uloric should seek emergency medical attention right if they experience any of the following symptoms:
Anyone currently using Uloric should not stop treatment without first talking to their doctor, as doing so can worsen gout.