Uloric Caused Coronary Artery Disease and Heart Bypass Surgery, Lawsuit Alleges

A product liability lawsuit filed by a California man indicates that side effects of Uloric, a gout medication, left him with coronary artery disease and resulted in the need for risky heart bypass surgery.

Robert Kay filed the complaint (PDF) in the U.S. District Court for the Northern District of Illinois on August 13, naming Takeda Pharmaceuticals as the defendant.

According to the lawsuit, Kay began taking Uloric in 2010, after his doctor prescribed it for the treatment of his gout condition. However, in August 2018 he had to undergo left heart catherization, which revealed he suffered from severe multivessel coronary artery disease. As a result of the heart problems caused by Uloric, Kay indicates he required coronary artery bypass grafting.

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 has rapidly become a blockbuster over the past 10 years. However, growing evidence has emerged in recent years that established a link between Uloric and heart risks, leading the FDA to require new cardiovascular warnings last year.

In February 2019, the FDA announced that the drug must carry the strongest label warning the agency can require a drug maker to place on their product, adding a Uloric “black box” warning about the risk of cardiovascular problems, which was not adequately reflected by the drug maker in the past.

“Defendants designed, marketed, and distributed Uloric in the United States, while knowing significant risks that were never disclosed to the medical and healthcare community, including Plaintiff’s prescribing doctor, Food and Drug Administration, to Plaintiff, and/or the public in general,” the lawsuit states. “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.”

While there were some signs of potential heart risks with Uloric when the drug was first released, it appears the FDA did not understand the true scope of the problems until Takeda released the results of a post-marketing clinical trial. However, growing evidence now suggests Takeda knew or should have known about the Uloric heart attack risks well before then, yet continued to market the drug without adequate warnings.

Although some critics have called for a Uloric recall to be issued, the FDA decided to allow the drug to remain on the market, with severe limitations on its approved uses.

Kay’s case is one of a growing number of Uloric lawsuits being pursued by individuals throughout the U.S., each raising similar allegations that strokes and other heart problems may have been avoided if Takeda had provided earlier warnings about the risks associated with the gout treatment.