Uloric Lawsuit Signed Cases
A medication used to prevent a painful form of arthritis may be lethal to some users. Early in 2019 the US Food and Drug Administration (FDA) announced a new warning on Uloric (also known as febuxostat) stating users faced in increased chance of death due to its use and limited how it should be prescribed. Litigation is being pursued by those who may have been injured due to its use and family members whose deaths may have been caused by the drug.
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The drug is made by Takeda Pharmaceuticals its use was approved by the FDA in February 2009. Uloric lowers the creation of uric acid in the body. If it build ups it can cause gout (a form of arthritis). Uloric should be used only by those who cannot take allopurinol, another gout treatment, or when it’s stopped working. Gout is a chronic disease that impacts about 8.3 million adults in the US.
Dangers of Uloric
The FDA announced in February 2019 there’s an increased risk of death when Uloric is used. The agency stated a “Boxed Warning” (the most prominent warning FDA can require) needed to be put on Uloric’s packaging because of a review of results from a safety clinical trial which found there’s an increased risk of heart-related death and death from all causes for Uloric users. The FDA limited Uloric’s approved use to patients who are not treated effectively or experience severe side effects with allopurinol.
When the agency approved Uloric packaging included a warning of possible cardiovascular events. Takeda was later required to conduct a large safety clinical trial which involved more than 6,000 patients treated with Uloric or allopurinol. The primary outcome of the study was a finding of increased risk to Uloric users of a combination of heart-related deaths, non-fatal heart attack, strokes, and inadequate blood supply to the heart requiring medical intervention, known as unstable angina.
The study results showed that overall, Uloric did not increase the risk of these combined events compared to allopurinol but when the outcomes were considered and evaluated separately, Uloric showed an increased risk of heart-related deaths and death from all causes.
Legal claims concerning Uloric filed against Takeda focus on the drug manufacturer’s failure to warn users of potential side effects caused by its medications. Despite the fact early clinical trials showed potential for increased risk of cardiovascular events, the company failed to adequately warn patients about those risks.
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