Attorneys helping people injured after taking Uloric to treat gout
Uloric (febuxostat), a drug manufactured by Takeda Pharmaceuticals, is used to treat gout. Gout is a chronic disease that affects approximately 8.3 million adults in the U.S. It happens when uric acid builds up in the body. Symptoms often appear suddenly. A patient may experience a sudden, severe attack of pain, swelling, redness and tenderness in the joints- often at the base of the big toe, ankle, knee, elbow, wrist, or fingers. Uloric was approved by the U.S. Food and Drug Administration (FDA) in 2009, but recently has received both a Drug Safety Communication and a Black Box Warning after serious injuries and deaths were reported.
FDA Drug Safety Communication for Uloric
On November 15, 2017, the U.S. FDA issued a Drug Safety Communication alert for an increased risk of heart-related deaths associated with Uloric use. This alert was issued after a safety trial involving over 6,000 patients. The primary outcome of that safety trial was a combination of heart-related death, heart attack, stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery.
FDA Black Box Warning for Uloric
In February 2019, the FDA issued another Drug Safety Communication and required the addition of a Black Box Warning for Uloric after concluding an increased risk of death associated with Uloric compared to another gout medication, allopurinol. The Boxed Warning is the most prominent warning the FDA can issue. The FDA stated that Uloric should be used only in patients who have failed or do not tolerate allopurinol. The FDA warned that anyone taking Uloric that experiences chest pain, shortness of breath, rapid or irregular heartbeat, dizziness, numbness or weakness on one side of your body, trouble talking, or severe headache should seek emergency medical attention.
Uloric Injury Lawsuits
Patients and loved ones of patients have filed lawsuits against Uloric maker Takeda Pharmaceuticals after reports of cardiac events and deaths were reported. If you or someone you care about was prescribed Uloric and suffered a heart attack, stroke, or death, contact us. Our attorneys have litigated hundreds of claims against large pharmaceutical companies and medical device manufacturers and can advise you or your legal rights and options.