Cincinnati, Ohio Pharmaceutical injury lawyer and drug recall attorney reviewing FDA cardiovascular warnings and representing plaintiffs nationwide in Uloric Lawsuits
The U.S. Food and Drug Administration (FDA) is adding an urgent Boxed Warning to the prescribing information for Uloric (febuxostat), noting there may be an increased risk of cardiovascular (CV) death and all-cause mortality in gout patients.
During a clinical trial, Uloric presented significant more cardiac risk to patients than an alternative gout medicine, allopurinol. The FDA is now limiting the approved use of Uloric to certain patients who are not treated effectively with allopurinol.
Uloric lawsuits and plaintiffs have reported drug-related cardiac events such as cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and unstable angina with urgent revascularization. Medical professionals and FDA officials urge gout patients taking Uloric to seek medical attention if they experience the following symptoms:
- Chest pain
- Trouble breathing
- Rapid heart rate
- Numbness or weakness on one side of the body
- Dizziness or vertigo
- Difficulty speaking
- Severe sudden headache
Gout patients with a history of cardiac issues or stroke should speak to their prescribing physicians about Uloric risks and its association with cardiac-related deaths.
Ohio Uloric Lawsuits & Cardiovascular Death Risks
The FDA approved Takeda Pharmaceutical’s Uloric in 2009 and included a warning about the potential for cardiovascular events. The drug is designed to improve gout patients’ symptoms by reducing levels of uric acid in the bloodstream. Febuxostat inhibits the oxidized and reduced forms of xanthine oxidase and decreases the formation of uric acid.
Even during the drug’s development, febuxostat was compared to allopurinol in clinical trials, and the data suggested a higher rate of cardiovascular events with febuxostat, strengthening evidence of company negligence in Uloric Lawsuits.
The Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) trial was conducted to determine whether febuxostat was noninferior to allopurinol with regard to major cardiovascular events in gout patients.
The study concluded Uloric presents a higher risk of cardiovascular death, non-deadly heart attacks, non-deadly strokes, and reduced blood supply to the heart (unstable angina).
If you or a loved one has suffered an injury or died after using Uloric (febuxostat), and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, a drug injury attorney, and he will help you answer critical questions regarding Uloric lawsuits.