A whistleblower lawsuit accuses Takeda Pharmaceuticals of downplaying the risk of renal failure from Uloric (febuxostat), a popular gout medication.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Uloric induced injury cases in all 50 states. If you or somebody you know has been diagnosed with renal failure, kidney disease, or needed dialysis, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is Renal Failure?
Renal failure (also called “End-Stage Kidney Disease”) occurs when the kidneys do not function well enough to filter toxins from the bloodstream. People with gout are more likely to develop renal failure. Over time, uric acid in the blood damages and scars the kidneys.
Is Uloric Safe for Kidney Patients?
Uloric is removed from the body through the kidneys. In patients with severe kidney impairment, the label on Uloric recommends limiting the dose to 40-mg a day. Takeda claims that no dose-adjustment is necessary for patients with mild or moderate kidney problems.
Did Takeda Downplay Uloric Kidney Risks?
Dr. Helen Ge, a former safety consultant at Takeda Pharmaceuticals, filed a whistleblower lawsuit accusing the drug-maker of downplaying the risk of renal failure from Uloric, as well as other side effects.
Whistleblower Lawsuit for Uloric Renal Failure & Other Side Effects
In the whistleblower lawsuit, Dr. Ge said she saw “frequent Uloric-related renal failure cases,” including 10 reports of patients who suffered acute renal failure in Uloric’s first 2 years on the market.
In one case, a retired physician switched his wife from allopurinol to Uloric. Her kidney function worsened so dramatically that he had to put her on dialysis. Dr. Ge said these reports are not on Uloric’s label.
Lack of Safety Studies for Kidney Patients
Another problem is that Uloric’s label claims that it is safe for patients with mild to moderate renal impairment. Takeda made this claim based on a “safety study” that only included 20 people, which is not nearly enough data to support the safety of Uloric for kidney patients.
Furthermore, Dr. Ge warned that acute kidney failure has been linked to a drug interaction between Uloric and Prevacid or Dexilant. Over 500 adverse events involving renal failure were reported to the FDA.
The whistleblower lawsuit (PDF) was filed on January 25, 2012 in the U.S. District Court for the District of Massachusetts — Case No. 1:11-cv-10343-PBS.
Signs & Symptoms of Renal Failure
- Less urine
- Fluid retention
- Swelling in the legs, ankles or feet
- Shortness of breath
- Fatigue
- Confusion
- Nausea
- Weakness
- Irregular heartbeat
- Chest pain or pressure
- Seizure or coma, in severe cases
Do I have a Uloric Lawsuit?
The Schmidt Firm, PLLC is currently accepting Uloric induced injury cases in all 50 states. If you or somebody you know has been diagnosed with renal failure, kidney disease, or needed dialysis, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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