The makers of Uloric face a wrongful death lawsuit brought by the family of a woman who suffered respiratory failure, severe, encephalopathy, multiple cerebral vascular accidents and ultimately died after taking the drug for the treatment of gout.
The complaint (PDF) was filed by Vicky Finley, on behalf of her mother, Mary Finley, in the U.S. District Court for the Northern District of Illinois on August 26, indicating that Takeda Pharmaceuticals failed to adequately warn about the potential side efects of Uloric.
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 rapidly became a blockbuster treatment over the past 10 years. However, growing evidence has emerged in recent years which established a link between Uloric and cardiovascular problems, leading the FDA to require new heart warnings last year.
In February 2019, the FDA announced 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 cardiovascular side effects, which was not adequately reflected by the drug maker in the past.
However, the lawsuit suggests the warning came too late for Mary Finley, of Texas, who was prescribed Uloric for the treatment of gout in 2016. She suffered a heart attack In February 2017 which resulted in multiple health problems, such as respiratory failure, strokes, brain swelling and finally Finley’s death in October 2017, a year and a half before the FDA updated Uloric’s cardiovascular risk warning.
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.
“In order to dominate the gout drug markets and to increase the sales of Uloric, Defendants misrepresented and/or concealed material facts regarding adverse events attributable to Uloric,” the lawsuit states. “Defendants suppressed knowledge of and failed to submit full and complete Periodic Adverse Drug Experience Reports to FDA, which would have shown that there were increased risks from Uloric associated with Drug/Drug Interaction while treating gout. Such conduct by Defendants deviated from the duties and conduct of a responsible pharmaceutical manufacturer and demonstrated a failure to ensure its own minimal compliance with requirements of the Federal Food Drug and Cosmetic Act.”
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.
Finley’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.