Uloric

Uloric is indicated to reduce uric acid levels in people with gout. U.S. health regulators recently warned that Uloric may be associated with a higher risk of cardiac death.

What is Gout?

Gout is a form of arthritis that affects roughly 4% of American adults. The condition is caused by a buildup of needle-like uric acid crystals in the joints, resulting in severe episodes of pain, tenderness, redness, warmth and swelling.

Uric acid is usually formed when the body breaks down purines, which are found in human cells and in many foods.

Normally, uric acid is filtered through the kidneys and passed out  of the body via urine. However, people with gout either overproduce uric acid or have kidneys that are unable to process it efficiently.

Gout can be triggered by medical or lifestyle factors. Medical factors that may lead to gout include:

  • Joint injury
  • Surgery or sudden, severe illness
  • Infection
  • Certain diuretic medications
  • Taking cyclosporine
  • Starting a uric acid-lowering treatment
  • Chemotherapy

Lifestyle triggers include:

  • Extreme dieting and fasting
  • Drinking alcohol in excess
  • Eating large amounts foods high in purines (red meats or shellfish)
  • Dehydration
  • Sweet sodas

How Does Uloric Work?

Uloric (febuxostat) belongs to a class of drugs called xanthine oxidase (XO) inhibitors.

Xanthine oxidase is a substance that plays a role in the formation of uric acid. Uloric prevents the formation of uric acid by blocking the release of xanith oxide.

Uloric is available in tablet form and is taken once per day, with an initial dose starting at 40mg. Dosage may be increased to 40 mg if needed.

Uloric Side Effects

Uloric should not be taken by patients who:

  • Have liver or kidney problems
  • Have a history of heart disease or stroke
  • Are pregnant or planning to become pregnant
  • Are breast-feeding or planning to breast-feed

Common side effects associated with Uloric include:

  • Joint pain/swelling/stiffness
  • Nausea
  • Skin rash
  • Dizziness

Serious Uloric side effects include:

  • Heart attack and other cardiovascular events
  • Liver enzyme abnormalities
  • Weakness
  • Numbness in extremities
  • Shortness of breath

FDA Warning for Uloric Heart-Related Death

The U.S. Food & Drug Administration (FDA) issued a safety alert for Uloric in November 2017, after preliminary results from a 6,000-patient clinical trial linked Uloric to a higher risk of cardiac death and all-cause mortality compared to another gout medication called allopurinol (Zyloprim and Aloprim).

The agency is continuing to evaluate this safety issue and will update the public when more information becomes available.

“Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat,” the FDA said in its alert. “Patients should talk to your health care professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your health care professional.”

  1. Takeda Pharmaceuticals, Inc. (2009) “Uloric: Highlights of Prescribing Information” https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021856s011lbl.pdf
  2. FDA (2017) “FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)” https://www.fda.gov/Drugs/DrugSafety/ucm584702.htm
Last Modified: May 14, 2018

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