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Uloric Lawsuit

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The gout drug Uloric (febuxostat) is the subject of a growing number of lawsuits from people who allege that Takeda Pharmaceuticals has failed to warn about severe, life-threatening side effects. Our lawyers now evaluating Uloric lawsuits on behalf of people who were injured.

Overview

Uloric (febuxostat) is a medication used to treat gout, which is a debilitating type of arthritis that occurs when uric acid builds up in the blood and causes inflammation in the joints. Uloric treats gout by inhibiting the enzyme xanthine oxidase, which reduces the amount of uric acid in the body. Uloric is manufactured by Takeda Pharmaceuticals, a Japanese-based pharmaceutical company. When it was approved by the FDA in 2009, it was the first new gout drug in over 40 years.

Uloric Lawsuits Filed Against Takeda Pharmaceuticals

Takeda Pharmaceuticals is facing multiple whistleblower lawsuits filed by Helen Ge, a former safety consultant for Takeda who alleged that the company withheld information about dangerous side effects — including drug interactions, kidney problems, liver damage, bone marrow failure, and more. In addition, a growing number of patients have filed lawsuits after developing these side effects.

FDA Updates Warnings and Precautions for Uloric

The Prescribing Information (PDF) for Uloric has been updated in January 2011 and November 2012 to include an expanding list of side effects. According to the Warnings and Precautions for Uloric:

  • Nausea
  • Liver failure
  • Kidney damage
  • Rhabdomyolysis
  • Heart attack
  • Stroke
  • Rash
  • Immune system disorders
  • Allergic reaction (anaphylaxis, rash, Stevens Johnson Syndrome)
  • Psychiatric disorders (psychotic behavior, aggressive thoughts)
  • Kidney and urinary disorders
  • Bone marrow failure
  • Severe bleeding
  • And more

Uloric and Liver Damage

Takeda Pharmaceuticals recommends that patients who use Uloric should have periodic blood tests to check for elevated liver enzymes. During clinical trials, 4-6% of Uloric patients had liver abnormalities, and 2% developed elevated liver enzymes that were 3-times the upper limit of normal.

Symptoms of liver damage from Uloric:

  • Stomach or abdominal pain (upper-right side)
  • Nausea
  • Vomiting
  • Jaundice (yellow discoloration of whites of the eyes, skin)
  • Loss of appetite
  • Itching
  • Malaise (generally feeling unwell)
  • Confusion
  • Cognitive changes (personality, behavior)

Uloric and Rhabdomyolysis

The FDA added rhabdomyolysis to the list of Uloric side effects in January 2011. People with rhabdomyolysis suffer from kidney damage after their muscle fibers break down and release a protein called myoglobin into the bloodstream.

Symptoms of rhabdomyolysis from Uloric:

  • Urine is dark or cola-colored
  • Less urine production
  • Muscle pain, stiffness, or aching (myalgia)
  • Weakness or trouble moving limbs
  • Painful, swollen, bruised, or tender areas of teh body
  • Nausea, vomiting
  • Confusion
  • Fever
  • Loss of consciousness

 

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