Side Effects of Uloric Caused Crippling Heart Attack, Lawsuit Claims

The family of an Alabama man has filed a lawsuit against Takeda Pharmaceuticals, alleging that the drug maker failed to warn about an increased risk of heart attacks linked to side effects of Uloric, a medication designed to treat gout.

The complaint (PDF) was filed in the U.S. District Court for the Northern District of Illinois on February 21, pursuing damages for Sherry Pugh, as the personal representative of Danny Ray Pugh, who is now deceased.

Danny Ray Pugh began taking Uloric in 2015, for the treatment of gout. However, in June 2017, he suffered a debilitating heart attack, which left him with severe injuries. While the lawsuit does not directly link the death to use of Uloric, Sherry Pugh does indicate that the drug maker knew or should have known about the heart risks with Uloric, yet failed to adequately warn users or the medical community.

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 established a link between Uloric and heart problems, 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 cardiac risks, including FDA concerns, when Uloric was first released, it appears the agency did not understand the true scope of the Uloric problems until Takeda released the results of a post-marketing clinical trial. However, growing evidence suggests Takeda knew or should have known about the risks, yet continued to market the drug without adequate warnings.

“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.

This complaint joins a growing number of other Uloric lawsuits filed by individuals throughout the U.S., which suggest if Takeda had provided earlier warnings, many consumers may have avoided suffering a heart attack, stroke or wrongful death by using other gout treatments.