ULORIC is a prescription medicine used to lower blood uric acid levels in adult patients with gout. Gout is a type of arthritis that occurs when uric acid crystals build up in the joints. Gout has been found to be more common in men than in women Gout is believed affects about 8.3 million people, or 4% of the U.S. population.
History: The FDA-mandated study, published in The New England Journal of Medicine in 2018, revealed that the “treatment with Uloric resulted in overall rates of major cardiovascular events that were similar to those associated with Allopurinol treatment among patients with gout who had coexisting cardiovascular disease. However, cardiovascular death and deaths from any cause were more frequent in the Uloric group than in the Allopurinol group”.
Takeda Pharmaceuticals is now under additional scrutiny as well as facing litigation if they withheld, altered or failed to properly disclose risk that that they were aware of, dating as far back to the initial clinical trials in 2009. Takeda is already facing legal problems over Uloric, with multiple Qui Tam lawsuits filed by a former safety consultant for the company. These suits that the company withheld information about dangerous side effects related to Uloric.
Uloric was the first new drug approved to treat Gout in 40 years. Unfortunately, this new treatment which promised relief for those who suffer from Gout, appears to have numerous significant and potentially life-threatening side effects that Takeda never warned the public about.
Initial clinical trials testing febuxostat prior to FDA approval linked the medication to possible increased risks of serious adverse cardiovascular outcomes, including heart attack, stroke and death. The FDA rejected the medication twice over these safety concerns before approving it in 2009 on the condition that the manufacturer conduct the now-completed large, post-market randomized clinical trial to further evaluate the cardiovascular risks.