According to allegations raised in a recently filed product liability lawsuit, side effects of Uloric caused a Vermont man to suffer a heart attack about two year after he first used the drug for treatment of gout.
The complaint (PDF) was filed by Mark Gomez late last month in the U.S. District Court for the Northern District of Illinois, indicating that Takeda Pharmaceutical knew or should have known about the heart risks with Uloric, yet failed to warn consumers or the medical community.
Gomez indicates that he was prescribed Uloric in 2015 for the treatment of gout. However, in June 2017, he suffered a myocardial infarction, more commonly known as a heart attack, which the lawsuit blames on use of Uloric, which now carries much stronger warnings about the increased risk of cardiovascular injury and death.
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 attacks, leading the FDA to require new warnings earlier this 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, including FDA concerns, when Uloric was first released, it appears that the agency did not understand the true scope of Uloric heart problems until Takeda released the results of a post-marketing clinical trial. However, growing evidence suggests that Takeda knew or should have known about the risks, yet continued to market the drug without adequate warnings.
Gomez’s lawsuit blames Takeda for failing to adequately test Uloric or warn about the side effects during the first decade the drug was on the market.
“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 complaint 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 a Uloric recall was urged by some critics, the FDA decided to allow the drug to remain on the market, with severe limitations approved uses.
This complaint joins a growing number of other Uloric lawsuits filed nationwide which suggest that if Takeda has provided earlier warnings, many consumers may have avoided suffering a heart attack, stroke or wrongful death by using other gout treatments.