According to allegations raised in a recently filed product liability lawsuit, a Florida man suffered a myocardial infarction and various heart problems on Uloric, which could have been avoided if makers of the gout drug had provided earlier warnings for users and the medical community.
Richard Willich filed the complaint (PDF) in the U.S. District Court for the Northern District of Illinois on May 12, indicating that Takeda Pharmaceuticals knew about the heart risks associated with Uloric for years before a “black box” warning was added to the gout drug in February 2019, yet continued to market the drug as a safe and effective treatment for gout.
At the time Uloric (febuxostat) was introduced in 2009, the FDA required Takeda Pharmaceuticals to conduct a post-marketing clinical trial, which was supposed to be complete by January 2014. However, according to the lawsuit, the study was delayed and data was not published until March 2018, concluding that all-cause death and cardiovascular mortality were higher among users of Uloric.
Although some critics called for a Uloric recall to be issued at the time, the FDA determined that Uloric could stay on the market with a “black box” warning about the heart risks, which is the strongest label warning that the agency can require a drug maker to place on their product.
Willich states that he began taking Uloric in 2013, after the drug was prescribed by his doctor for treatment of gout. However, in May 2016 he suffered a non-ST elevation myocardial infarction (more commonly known as a heart attack), which required hospitalization and surgical intervention. He was also diagnosed with acute coronary syndrome, coronary artery disease, and atherosclerosis, which he indicates were all a result of his ingestion of Uloric.
“Throughout the time Defendants marketed Uloric, Defendants withheld material adverse events from the public, medical community and FDA,” the lawsuit states. “Defendants failed to disclose the serious link between Uloric use and ‘Major Adverse Cardiovascular Events’ (‘MACE’), which ultimately culminated in a mandatory FDA imposed ‘Black Box’ Warning. Ultimately, tens of thousands of patients, including Plaintiff, were placed a risk and harmed as a result of this misleading conduct.”
The case joins a growing number of similar Uloric lawsuits now being pursued by former users of the drug who have suffered heart problems, indicating that Takeda knew or should have known about risks for years, yet continued to market the drug without properly investigating reports of heart problems on Uloric to determine whether the design of the drug was causing the injuries.
Willich maintains his physicians would not have prescribed Uloric if information about the health risks had been disclosed.