Uloric Lawsuit Claims Manufacturer Deceived Patients Over Heart Risks

A Tennessee man says he suffered a heart attack from Uloric, due to the manufacturer’s decision to mislead the medical community, regulators and consumers about the safety profile of the popular gout treatment.

Timothy Dixon filed the complaint (PDF) against Takeda Pharmaceuticals in the U.S. District Court for the Northern District of Illinois on April 15, indicating the side effects of Uloric have endangered thousands of users, who were never warned about the potential heart risks linked to the medication.

In 2011, Dixon was prescribed Uloric for the treatment of a diagnosed gout condition and high blood uric acid levels. However, in April 2019, he suffered a heart attack and discontinued Uloric use, which the lawsuit blames for Dixon’s heart problems.

The lawsuit indicates Takeda Pharmaceuticals has long known about the link between Uloric and heart attack risks, but attempted to keep the information away from the public and federal regulators.

Dixon claims the company knew of several fatal or life-threatening adverse reactions linked to Uloric use, including those from interactions with other drugs, but failed to add those concerns to the warning label.

“Defendants ignored reports from patients and health care providers throughout the United States of Uloric’s failure to perform as intended, which led to the severe and debilitating injuries suffered by Plaintiff and numerous other patients,” the lawsuit states. “Rather than doing adequate testing to determine the cause of these injuries or rule out Uloric’s design as the cause of the injuries, Defendants continued to market Uloric as a safer and more effective prescriptive drug as compared to other available alternative treatment for hyperuricemia and gout.”

Uloric (febuxostat) was introduced by Takeda Pharmaceuticals in 2009, and is designed 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 attacks, leading the FDA to require new 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 heart problems, which was not adequately reflected by the drug maker in the past.

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 called for a Uloric recall, the FDA decided to allow the drug to remain on the market, with severe limitations on its approved uses.

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