A lawsuit filed on August 13 by a California man claims that the gout medication Uloric caused his coronary artery disease and his need for heart bypass surgery.
The lawsuit names Takeda Pharmaceuticals as the defendant and says the man started taking Uloric in 2010 for gout. The man needed left heart catheterization in August 2018 and this revealed severe multivessel coronary artery disease. The man claims this required coronary artery bypass grafting.
The lawsuit claims Takeda formed a “scheme to downplay the number of adverse events stemming from Uloric use.”
“Defendants failed to comply with [adverse event reporting] requirements, constructing a scheme designed to intentionally conceal a substantial number of adverse event reports from FDA and the public,” the lawsuit claims. “Upon information and belief, defendants submitted false periodic adverse drug experience reports to FDA. Defendants did so because it failed to include numerous drug/drug interaction adverse events as serious adverse events.”
The lawsuit claims that Takeda knew about the serious risks associated with Uloric and failed to warn the public about these risks.
“Defendants designed, marketed, and distributed Uloric in the United States, while knowing significant risks that were never disclosed to the medical and healthcare community, including plaintiff’s prescribing doctor, Food and Drug Administration, to plaintiff, and/or the public in general,” the lawsuit says. “Further, defendants failed to provide adequate warnings to patients and the medical community, including plaintiff’s prescribing physician, of the risks associated with using the drug.”
The FDA asked Takeda to provide further data about the increased risk of cardiac thromboembolic events prior to approving their new drug application (NDA) for Uloric. The FDA wasn’t satisfied with the “re-adjudication of previously reported events” Takdea provided them as a response, the lawsuit claims, finding the data inadequate. The FDA eventually agreed to grant Uloric’s NDA under the condition Takeda do more research into the drug’s cardiovascular safety, concluding the study by January 2014.
“Despite the timetable laid out by FDA, the post-marketing trial conducted by defendants did not conclude until several years after required by FDA,” the lawsuit claims. The study eventually concluded that “all-cause mortality and cardiovascular mortality were higher with febuxostat than with allopurinol,” according to the lawsuit.
The FDA added a black box warning to Uloric’s label warning of the increased risk of death associated with Uloric after receiving the results to the study. The label never warned of this risk prior to this, and the lawsuit claims this risk wasn’t noted by the label despite Takeda knowing about the risk.
For more information on Uloric lawsuits, visit https://www.personalinjurylawcal.com/uloric-side-effects-lawsuit/