According to allegations raised in a recently filed product liability lawsuit, Takeda Pharmaceuticals failed to warn users and the medical community for years about the link between Uloric and cardiac arrest, concealing information about potential side effects of the popular gout drug.
Michael Hall filed the complaint (PDF) in the U.S. District Court for the Northern District of Illinois on June 1, indicating that Uloric side effects caused him to suffer a cardiac arrest which required medical treatment and left him with permanent injuries.
Uloric (febuxostat) was introduced by Takeda Pharmaceuticals in 2009, as a prescription treatment 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 became a blockbuster drug in the United States.
Hall indicates he was first prescribed Uloric in 2010, after being diagnosed with gout. After continuing to take the medication for years, Hall states that he suffered a cardiac arrest in June 2018, which he directly links to side effects of the drug.
“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 there were some signs of potential cardiac risks linked to Uloric when the medication was first introduced, Takeda sold the drug for years without providing warnings and information to users and the medical community.
That all changed last year, when the FDA required Takeda Pharmaceuticals to add a new Uloric “black box” warning in February 2019, which is the strongest label warning the agency can require a drug maker to place on a medication.
Although some critics called for a Uloric recall at that time, arguing that the risk of cardiac arrest from Uloric outweighed any benefits provided by the gout treatment, the FDA decided to allow the drug to remain on the market, with severe limitations on its approved uses.
Hall’s complaint now joins a growing number of Uloric lawsuits being pursued by former users of the drug throughout the U.S., each raising similar allegations that cardiac arrest, heart attacks and other serious problems may have been avoided if Takeda had provided earlier warnings and information for users of the gout treatment.