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Uloric, the common brand name for the medication Febuxostat, manufactured by Takeda Pharmaceuticals, entered the US market in 2009. Uloric is a pill that is advertised to manage gout, a condition that approximately 8.3 million people in the United States suffer from. Gout is a type of arthritis that causes pain, redness, and swelling in joints such as the great toe, when a substance called uric acid builds up in the body.
Eleven years after it’s an introduction to the market, lawsuits have stacked-up against Takeda, as we now know that Uloric is associated with several adverse reactions. Lawsuits claim that Takeda Pharmaceuticals failed to warn consumers about the potential adverse reactions caused by Uloric. Adverse reactions include kidney damage, liver damage, cardiovascular accidents (stroke), and blood clots disorders such as pulmonary embolism and deep vein thrombosis.
Uloric appeared to be bad news right from the start and Takeda struggled to get the drug on the market. Uloric initially applied for FDA approval and the application was rejected in 2005. The approval was again denied in 2008, then Uloric finally received approval in 2009.
Not long after it entered the market in 2010, Dr. Helen Ge sued Takeda, states that Takeda intentionally hid information about Uloric’s serious side effects. Additionally, she claimed that Takeda covered up negative interactions with two drugs that treated gastrointestinal reflux disease. Despite her claims; the case was somehow dismissed and Takeda carried on.
Years later, in 2017 the FDA posted a safety communication that they were going to evaluate the increased risk of heart-related death from all causes with the gout medication Uloric.
On February 21, 2019, an Updated Safety Announcement was made, and the FDA concluded that there is, in fact, an increased risk of death with Uloric when compared to other gout medications. At that time, a Black Box Warning was issued. Uloric was also limited for approval in only cases where alternative gout medication did not work.
Furthermore, Public Citizen, a non-profit organization filed a petition that the FDA, “Immediately require removal from the market of all medications containing febuxostat, which is currently marketed under the brand name Uloric.” However, for unknown reasons, the petition was rejected.
How Takeda Pharmaceuticals has managed to continue to keep Uloric from being pulled off the market, is shocking. Was there really a need for Uloric in the first place? Gout medications that were previously introduced to the market worked well and cost less.
Since FDA Uloric warnings, Takeda is still trying to get FDA approval under different names. A rising number of lawsuits are expected to be seen in 2020, with increased consumer awareness of the adverse drug reactions.
Elena Borrelli is a certified physician assistant, or PA, with 18 years of experience in health care. She has worked 11 years as a PA in diverse clinical settings, including surgery, trauma, primary care, women’s health and quality management. Over the years, she has authored several publications and lectured on various health care-related topics.