Lawsuit Alleges Uloric Heart Attack Risk Not Adequately Disclosed By Gout Drug Makers

Takeda Pharmaceuticals has failed to adequately disclose the heart attack risk for Uloric users, according to allegations raised in a product liability lawsuit filed by a Washington state man who experienced cardiac side effects following use of the gout medication.

The complaint (PDF) was recently filed in the U.S. District Court for the Northern District of Illinois by Steven Haas, who indicates that he suffered a heart attack in April 2017, which may have been avoided if warnings and information had been provided to users and the medical community when was first prescribed the treatment.

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.

Haas’s lawsuit notes that it took years for manufacturers to get Uloric through the FDA’s approval process, specifically due to cardiovascular concerns.

“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.”

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.

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