Febuxostat, more commonly known as Uloric, is a gout medication manufactured by Takeda Pharmaceuticals. Gout is a type of arthritis that occurs when uric acid builds up in the joints, causing extreme joint pain, inflammation, and potentially limiting a person’s range of motion. Uloric was released in 2009 after several years of clinical trials, making it the first new gout drug approved by the FDA in nearly 40 years.
This approval came with one stipulation: Takeda was required to conduct post-launch clinical trials to further investigate the possible side effects. Throughout the trial process, Uloric was found to increase the risk of potentially fatal cardiovascular issues, including heart attacks and strokes. Furthermore, the FDA realized that Takeda’s trials were insufficient and had failed to report the potential for heart-related death. Over half of the patients withdrew from the trial early, which skewed the results.
After conducting reviews, the FDA is putting new restrictions on the drug. Uloric now requires a boxed warning describing the possible dangerous side effects. Additionally, the FDA is limiting its approval of Uloric to patients who could not tolerate or failed to respond to other gout medications.
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Takeda Pharmaceuticals is facing heat not only from the FDA but also from its own safety consultants, who have filed multiple Qui Tam lawsuits. The drug manufacturer is being sued for failing to disclose other possible side effects, including kidney problems, liver damage, and dangerous drug interactions.
If you or a loved one was harmed by Uloric or other drugs due to big pharma’s negligence, consult one of our skilled personal injury lawyers. When dealing with these complex pharmaceutical liability cases, it may be crucial to have a knowledgeable attorney to guide you through the process and fight for appropriate compensation.