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Texas Woman Blames Uloric for Family Member’s Heart Attack

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, who passed away on October 31, 2017. She claims that after using the gout medication, the decedent suffered from serious injuries that led to her ultimate death.

Plaintiff Claims Uloric Caused Her Loved One’s Heart Attack

According to the complaint, the decedent started taking Uloric (febuxostat) in 2016. At that time, her doctor prescribed the medication to treat her medically diagnosed gout condition. The drug manufacturer, Takeda Pharmaceuticals, represented the drug to be an appropriate treatment for this purpose.

Gout is a type of arthritis caused by a buildup of uric acid in the blood. Symptoms include sudden, severe attacks of pain, swelling, redness, and tenderness in the joints, often in the joint at the base of the big toe. The attacks can wake a patient up in the middle of the night and can cause the joint to feel so hot that it can be compared to being “on fire.”

The FDA approved Uloric in 2009 for use in the chronic management of uric acid buildup in patients with gout. The medication lowers the amount of uric acid in the blood, which can help reduce symptoms of the condition. At the time of the 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.

The FDA also required the manufacturer to conduct an additional clinical trial to determine whether the use of Uloric was associated with any risk of cardiovascular problems. The results of that study, which was completed in July 2017, showed that mortality rates, whether caused by a cardiovascular or other event, were higher in patients taking Uloric than in patients taking the leading gout medication, allopurinol.

Based on the study results, in February 2019, 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. The FDA also limited the approved use of Uloric to patients who did not have success with allopurinol.

The plaintiff’s family member, after taking Uloric for less than a year, suffered a heart attack that required medical treatment. The plaintiff believes that Uloric caused the injury, and seeks damages associated with those injuries. She adds that the defendants ignored reports from patients and health care providers throughout the U.S. of Uloric’s failure to perform as intended.

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 treatment[s]…”

Defendants Took No Proactive Action to Warn Patients of the Risks

At the time the FDA approved Uloric for the U.S. market, Takada had been interacting with the agency about the drug for nearly five years. The FDA asked the pharmaceutical company to provide additional information about the potential cardiovascular effects of the drug on several occasions.

Even after approval, the FDA required the company to perform the post-marketing study noted above. The trial involved about 6,200 patients with gout and cardiovascular disease and was called the “Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES)” trial. Though the results showed that overall rates of cardiovascular events were similar in patients taking Uloric or allopurinol, 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.

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