According to allegations raised in a wrongful death lawsuit filed by the family of an Illinois woman, side effects of Uloric caused a fatal heart attack, which may have been prevented if an alternate gout treatment had been used.
The complaint (PDF) was filed by Sara Stewart in the U.S. District Court for the Northern District of Illinois, pursuing claims on behalf of herself and the estate of her mother, Tina Stewart, indicating that Takeda Pharmaceuticals failed to adequately warn consumers and the medical community about the heart risks linked to Uloric.
Tina Stewart was prescribed Uloric in 2018, for the treatment of gout. However, later that year, in May 2018, she suffered a heart attack and died July 13, 2018, due to complications from the sudden cardiac arrest, coronary artery heart disease and ischemic cardiomyopathy.
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 which indicated it was a safe and effective treatment for gout, Uloric rapidly become a blockbuster drug 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.
Stewart’s lawsuit claims the company purposefully concealed evidence of Uloric heart problems, and that her mother’s doctor never would have prescribed the treatment if the risk information had been disclosed.
“Contrary to the adverse event reporting promises and certifications that Defendants had given to the FDA, Defendants initiated a system to intentionally conceal a substantial number of adverse event reports and thus had no intention of complying with its certifications and promises,” the lawsuit states. “In order to dominate the gout drug markets, to increase the sales of Uloric and to facilitate the continued reimbursement from Government Healthcare Programs for claims made by providers for Uloric, Defendants misrepresented and/or concealed material facts regarding adverse events attributable to Uloric.”
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.
Stewart’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.