Uloric Stroke Lawsuit Filed Over Side Effects of Gout Drug Sides

According to allegations raised in a recently filed product liability lawsuit, cardiac side effect of Uloric caused an Arkansas woman to suffer a stroke and other injuries, which she indicates may have been avoided if the maker of the gout drug had provided adequate warnings to consumers and the medical community.

Maxine Fisher filed the complaint (PDF) on July 14 in the U.S. District Court for the Northern District of Illinois, indicating Takeda Pharmaceuticals failed withheld information about the link between Uloric and strokes, heart attacks and other cardiovascular adverse events.

According to the lawsuit, Fisher was prescribed Uloric after she was diagnosed with gout in 2014, and continued to use the drug for several years. However, in September 2017, she suffered a stroke, which the lawsuit claims was caused by the gout drug.

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 problems, 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 heart problems, which was not adequately reflected by the drug maker in the past.

“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.”

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.

Fisher’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.