More than eight million adults in the United States suffer from gout, an intensely painful form of arthritis that can occur suddenly and affect virtually anyone. For nearly 10 years, the go-to treatment for gout was Uloric, a prescription medication marketed and sold in the U.S. by Takeda Pharmaceuticals. However, Uloric has since been red flagged by the U.S. Food and Drug Administration (FDA), due to clinical trial findings linking the gout medication to an increased risk of cardiovascular death and death from all causes compared to an older gout medication called allopurinol.
Being that Uloric is prescribed to treat a nonfatal, albeit painful, condition, the potential risk of heart-related death and death from all causes in patients taking Uloric far outweigh any possible treatment benefits of the medication. In light of this troubling information, consumers who took Uloric for years to relieve gout symptoms are now pursuing legal claims against Takeda for heart attack, stroke, death, and other devastating side effects. To find out if you are eligible to file a Uloric injury claim against Takeda Pharmaceuticals, contact Consumer Safety Watch today. We understand how devastating pharmaceutical drug side effects can be, especially those that put patients at risk for death, and we are ready to review your potential claim in a free, no-obligation case evaluation. Call us today for help.
Uloric (febuxostat) is one of only a few prescription medications that have been approved by the FDA for the treatment of hyperuricemia in adults suffering from chronic gout, a condition caused by a buildup of uric acid in the blood. Uric acid is a naturally occurring substance in the body, but when it accumulates in the bloodstream, it can cause sudden attacks of pain, swelling, redness, and tenderness in one or more joints. Uloric belongs to a class of drugs known as xanthine oxidase inhibitors, which are designed to relieve the symptoms of gout by limiting the amount of uric acid the body produces.
Before Uloric was even approved by the FDA, clinical trials had already indicated that patients taking the gout medication faced a higher risk of heart-related problems, including heart attacks, strokes, and heart-related death, compared to patients taking allopurinol. When Uloric finally garnered FDA approval in 2009, it was on one condition: that Takeda would conduct a safety clinical trial (known as the Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES) trial) to compare the potential cardiovascular risks of Uloric and allopurinol. The first FDA warning about possible Uloric side effects came in November 2017, eight years after the gout medication entered the market, when the FDA alerted the public about preliminary results from the CARES trial, which showed an increased risk of heart-related death in patients taking Uloric treatment compared those taking allopurinol.
In February 2019, after reviewing the results of the CARES clinical trial, the FDA required Takeda to add a black box warning – the agency’s strongest warning for medications – to the Uloric label notifying consumers about the risk of life-threatening side effects associated with the gout medication. “This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric,” the FDA reported in a 2019 drug safety communication. The FDA also restricted the use of Uloric to certain patients who cannot be treated effectively or experience serious side effects with allopurinol. Unfortunately, by this time, Uloric had already been on the market for a decade and was considered a first-line treatment for adults suffering from gout.
It was only fairly recently that the risks of heart-related death and death from all causes from Uloric were brought to the public’s attention, and so the Uloric litigation is still in its early stages. That being said, there are more than a million people in the U.S. alone who have taken Uloric, and we continue to see lawsuits filed on behalf of consumers who were prescribed Uloric to treat gout and subsequently suffered from serious complications like heart attack, stroke, or death. Each of the Uloric lawsuits currently pending against Takeda Pharmaceuticals in courts across the country involve similar allegations that the drug maker failed to warn patients about the potential risk of severe side effects associated with the gout medication. Plaintiffs further allege that the company failed to adequately research the cause of Uloric’s elevated cardiovascular risk and continued marketing the medication as a safe and effective treatment for gout despite these known health risks.