A Texas woman recently filed a new Uloric Lawsuit in the U.S. District Court for the Northern District of Illinois. She filed the case individually and on behalf of the estate of her family member. She claims that after using the gout medication, the decedent suffered from serious injuries that led to her ultimate death.
According to the complaint, the decedent started taking Uloric in 2016. The drug manufacturer, Takeda Pharmaceuticals, represented the drug to be an appropriate treatment for gout.
The FDA approved Uloric in 2009 for use in the chronic management of uric acid buildup in patients with gout. At the time of approval, the FDA required a warning to be placed on the product label alerting doctors and patients to the possible increased risk of cardiovascular events.
Based on the results of an additional study, the FDA required Takeda to add a black box warning – the most serious type – to the product label, warning patients and doctors of the dangers.
In the complaint, the plaintiff alleges that “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 treatments…”
Even after approval, the FDA required the company to perform a post-market study. The trial involved about 6,200 patients with gout and cardiovascular disease. Though the results showed overall rates of cardiovascular events were similar in patients taking Uloric, the difference was in the mortality rates.
The study was completed in 2017 and published in the New England Journal of Medicine in 2018. Yet the manufacturer did nothing to warn doctors and patients about the risks until required by the FDA in 2019.