Uloric is a gout medication manufactured by Takeda Pharmaceuticals. Takeda is facing a growing number of lawsuits alleging that they did not warn about the risk of heart attacks, strokes, and death.
Need a Texas Uloric Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with a heart attack, stroke, or another severe side effect of Uloric, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
FDA Links Uloric to Increased Risk of Heart Attacks, Strokes, Death
May 2019 — The FDA has issued a warning that Uloric is associated with an increased risk of death compared to the gout drugs allopurinol (Zyloprim and Aloprim). The FDA conclusion is based on a safety study that linked Uloric to heart attacks, strokes, and death.
What is the Risk?
FDA Adds Boxed Warning on Uloric
The FDA is placing the strongest warning label — a Boxed Warning — on the medication guide for Uloric to inform patients and doctors about the risk of death from Uloric. Furthermore, the FDA is limiting Uloric’s approved use to patients who are not treated effectively or experience severe side effects with allopurinol.
What Should I Do?
Patients with a history of heart problems or stroke should tell their healthcare professional. Seek emergency medical attention right away if you experience symptoms of a heart attack or stroke while taking Uloric.
Symptoms of a Heart Attack or Stroke
- Chest pain
- Shortness of breath
- Rapid or irregular heartbeat
- Numbness or weakness on one side of your body
- Trouble talking
- Sudden severe headache
What is Uloric?
When the FDA approved Uloric (febuxostat) in February 2009, it was hailed as the first new gout drug in over 40 years. It works by inhibiting an enzyme called xanthine oxidase, which the body needs to create uric acid. This reduces uric acid levels, which treats painful joint inflammation in gout users.
Uloric Lawsuit Information
In 2012, Takeda Pharmaceuticals was hit with two whistleblower lawsuits filed by Helen Ge, a former safety consultant who alleged that the company was not reporting severe side effects of Uloric and Actos (pioglitazone), including bladder cancer, bone marrow failure, and more.
FDA Safety Warnings for Uloric Side Effects
- Liver failure
- Kidney damage
- Heart attack
- 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 Failure
Liver failure is one of the most severe side effects of Uloric, which is why patients should have periodic blood tests to check liver function. During clinical trials, elevated liver enzyme levels were one of the most common side effects, estimated to occur in 4-6% of users. Levels returned to normal after Uloric was discontinued. About 2% of Uloric patients had elevated liver enzymes 3-times the upper-limit of normal.
Symptoms of liver damage from Uloric:
- Abdominal pain and discomfort (upper-right side)
- Nausea, vomiting
- Jaundice (yellowing of the skin and whites of the eyes)
- Malaise (generally feeling unwell)
- Confusion, disorientation
- Changes in personality or behavior
Uloric and Rhabdomyolysis
In January 2011, the side effect information for Uloric was updated to include rhabdomyolysis. This is a life-threatening disease that occurs when muscle fibers break down, release myoglobin in the bloodstream. When the kidneys filter myoglobin, it clogs small blood vessels and causes kidney damage.
Symptoms of rhabdomyolysis from Uloric:
- Dark-colored urine
- Decreased production of urine
- Muscle stiffness, weakness, tenderness, or aching
- Joint pain
Need a Uloric Lawyer in Texas?
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