Uloric Risks Concealed from FDA, Medical Providers and Users of Gout Drug, Lawsuit Alleges

After using the gout drug Uloric for about six years, a Philadelphia man indicates that side effects caused him to suffer a heart attack, alleging in a recently filed lawsuit that Takeda Pharmaceuticals withheld information about the health risks from regulators, doctors and users for years.

Michael Farrell filed the complaint (PDF) last month in the U.S. District Court for the Northern District of Illinois, indicating he suffered a myocardial infarction in June 2016, after taking the gout drug since about 2010.

Uloric (febuxostat) was introduced by Takeda Pharmaceuticals in 2009 as a prescription medication intended to lower the blood uric levels among adults diagnosed with gout.

Amid aggressive marketing, the drug rapidly became a blockbuster treatment in the United States. However, after growing evidence established a link between Uloric and heart risks, the FDA required new warning information to be added to the drug label in 2019.

Farrell indicates Takeda’s failure to warn him, his doctor or the medical community at large contributed to his heart attack and numerous injuries among other patients.

“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,” the 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.”

The case joins a number of similar Uloric lawsuits now being pursued by former users of the drug, alleging they may have avoided a heart attack, stroke or other injuries by using a different treatment for gout.

Although some critics have called for a Uloric recall to be issued due to the heart risks, the medications has remained on the market, with severe limitations on its approved uses. However, Farrell and other plaintiffs allege that earlier actions could have been taken if the drug maker had not concealed information about the risks associated with their blockbuster drug.