Uloric Heart Attack Lawsuit Claims Takeda Failed to Warn on Cardiac Risks

Published on May 18, 2020 by Laurie Villanueva

A woman from Illinois has filed a new Uloric lawsuit alleging the gout drug caused her mother’s fatal heart attack.

Uloric Heart Attack Allegations

According to a complaint filed in the U.S. District Court, Northern District of Illinois, on May 7th, Tina Stewart was prescribed Uloric in 2018 to treat gout, a painful form of arthritis caused by excessive levels of uric acid in the blood. On May 8, 2018, she  presented at the hospital with frequent and excessive chest pain, resulting in a diagnosis of non-ST-elevation myocardial infarction. (Case No. 1:20-cv-02768)

Although Stewart was discharged two days later, she would die in the hospital on July 13, 2018. The causes of death were listed as sudden cardiac arrest, coronary artery heart disease, and ischemic cardiomyopathy. Her  daughter claims that Uloric — which she continued to take until her death – was the direct and proximate cause of Stewart’s heart attack and other fatal cardiac complications.

“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, Decedent, and numerous other patients,” the Uloric 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.”

FDA Orders Uloric Black Box Warning

The U.S. Food & Drug Administration (FDA) approved Uloric in 2009, following a five-year delay that reflected the agency’s concern over possible heart side effects. As a condition of that approval, Takeda Pharmaceuticals was required to conduct a post-market study to better asses those risks.

The results of that study – The Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) – were finally published in the New England Journal of Medicine in March 2018, and suggested the risk of all-cause mortality and cardiovascular death was higher with Uloric compared to an older gout drug called allopurinol.

Nearly a year later, the FDA directed Takeda to add a new Black Box Warning – the strongest possible safety notice – to the Uloric label and rescinded its status as a first-line treatment for gout. The agency has advised current Uloric patients to let their doctor know if they have a prior history of heart problems and seek medical attention right away if they experience any of the following symptoms:

  • Chest pain
  • Shortness of breath
  • Rapid or irregular heartbeat
  • Numbness or weakness on one side of your body
  • Dizziness
  • Trouble talking
  • Sudden severe headache

Doctors have been advised to reserve Uloric for patients who have failed or do not tolerate allopurinol. These individuals should be apprised of Uloric’s possible heart side effects and be urged to seek immediate medical attention immediately if they experience any signs or symptoms of heart attack or other cardiac problems.

Uloric patients should not stop taking the medication without first talking to their doctor, as doing so could cause their gout to worsen.

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