Uloric Manufacturer Hid Cardiovascular Risks from Consumers, Lawsuit Alleges

A growing number of lawsuits brought against the makers of Uloric, a blockbuster medication once considered the go-to treatment for adults dealing with gout, allege that Takeda Pharmaceuticals deliberately withheld pertinent information about the potential cardiovascular risks associated with Uloric treatment from consumers and the medical community for years. If you have experienced a heart attack or stroke, or if your loved one died from a fatal cardiovascular event, and you believe Uloric treatment to be the cause, you may have grounds to file a Uloric lawsuit against Takeda Pharmaceuticals, too. Don’t wait to pursue the compensation you deserve for your pharmaceutical drug-related injuries and losses; call Consumer Safety Watch today to find out if you qualify for a Uloric injury claim.

Millions Have Been Prescribed Uloric for Gout

Takeda Pharmaceuticals introduced Uloric (febuxostat) in the United States in 2009 as an alternative to allopurinol, which had been on the market since the 1960s. The prescription medication was designed to lower blood uric acid levels in adults with gout, a form of arthritis characterized by chronic joint pain, swelling and redness. Amid aggressive marketing on Takeda’s part, Uloric quickly became a blockbuster gout medication, and for ten years, Uloric was touted as a safe and effective treatment for chronic gout sufferers. Given the fact that there is no known cure for gout and few medications are approved to treat the condition, most people who were prescribed Uloric took the drug long-term. Everything changed in 2019, however, when the U.S. Food and Drug Administration (FDA) required new warnings to be added to the Uloric label regarding an increased risk of heart-related death and death from all causes.

Uloric’s Black Box Warning

According to the FDA, the updated Uloric warning was based on the agency’s “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 clinical trial in question involved more than 6,000 patients who were randomly assigned treatment with either febuxostat or allopurinol. Researchers involved in the trial reported 15 heart-related deaths and 26 deaths from any cause for every 1,000 patients taking Uloric, compared to only 11 heart-related deaths and 22 deaths from any cause for every 1,000 patients taking the older gout drug allopurinol. As a result of these findings, Uloric now carries a black box warning indicating that “there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol.” The FDA has also restricted the use of Uloric to certain patients for whom allopurinol treatment is ineffective or inappropriate.

Uloric Lawsuits Filed Against Takeda Pharmaceuticals

In the short amount of time that has passed since the FDA added the new Uloric warning, Takeda Pharmaceuticals has been named in a number of lawsuits alleging Uloric-related side effects like heart attack, stroke and fatal cardiovascular events. One of the most recent Uloric injury lawsuits naming Takeda Pharmaceuticals as a defendant was filed late last month in the U.S. District Court for the Northern District of Illinois. The plaintiff in the lawsuit, Michael Farrell, alleges that side effects of Uloric caused him to suffer a heart attack, which he blames on Takeda’s failure to disclose the cardiovascular risks of Uloric treatment to patients, healthcare providers, or the medical community.

“Defendants designed, marketed, and distributed Uloric in the United States, all the while knowing significant risks that were never disclosed to the medical and healthcare community, including Plaintiff’s prescribing doctor, the Food and Drug Administration, to Plaintiff, and/or the public in general,” Farrell’s Uloric lawsuit states. “Throughout the relevant period, Defendants concealed their knowledge of Uloric’s defects from Plaintiff, FDA, the public in general and the medical community, including Plaintiff’s prescribing doctor. Further, Defendants failed to provide adequate warnings to patients and the medical community, including Plaintiff’s prescribing physician, of the risks associated with using the drug.” According to Farrell’s claim, he took Uloric as a treatment for gout for approximately six years, from about 2010 to 2016. In June 2016, he reportedly suffered a myocardial infarction, which he alleges was caused by his use of Uloric.

Farrell’s claim joins a growing number of lawsuits filed by former Uloric users who allege that they suffered potentially life-threatening side effects or were exposed to serious health risks as a result of Takeda’s failure to warn about the risk of heart-related death and death from all causes tied to Uloric. The plaintiffs in the mounting Uloric litigation contend that, had Takeda provided adequate warnings about the possibility of Uloric causing serious and potentially life-threatening cardiovascular events in users, they could have avoided suffering a heart attack, stroke or other serious injuries by using an alternative gout treatment.

Contact Us Today if You Have Been Injured by Uloric

In light of the serious heart-related risks associated with Uloric treatment, some critics have called on the FDA to remove the gout medication from the market. Unfortunately, the FDA has yet to issue a Uloric recall, and the potentially dangerous drug remains available for consumer use. If you believe you have been adversely affected by side effects of Uloric, we are here to help. Contact us today to discuss the possibility of filing a Uloric lawsuit against Takeda Pharmaceuticals for compensation.