Uloric is indicated to reduce uric acid levels in people with gout. However, a recent safety review confirmed that the drug is associated higher risk of heart-related 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.

Febuxostat 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 febuxostat 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 Launches Review of Uloric Heart-Related Death Risk

The U.S. Food & Drug Administration (FDA) issued a safety alert for febuxostat 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 indicated its safety review was ongoing, and said it would 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.”

In January 2019, an FDA panel of outside advisers concluded that Uloric side effects outweigh its benefits for most patients, with the exception of those who can’t use allopurinol. By a 12-to-1 vote, the panel members recommended that febuxostat remain a first-line gout treatment ONLY for those patients. Additionally, the panel recommended that  the risk heart-related death be highlighted in a Black Box Warning – the most serious class of safety warning — on the Uloric label.

FDA Orders Uloric Black Box Warning

The FDA ordered the Black Box Warning just one month later, confirming that Uloric was associated with a higher risk of death, including cardiovascular-related death compared to other gout treatments. Additionally, the agency advised physicians and other  healthcare providers to limit Uloric to patients who have failed or cannot tolerate allopurinol.

According to the FDA, patients taking Uloric should seek immediate emergency medical if they experience the following symptoms:

  • Chest pain
  • Shortness of breath
  • Rapid or irregular heartbeat
  • Numbness or weakness on one side of your body
  • Dizziness
  • Trouble talking
  • Sudden severe headache
  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
  3.  FDA (2019) “FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)” https://www.fda.gov/Drugs/DrugSafety/ucm631182.htm
Last Modified: March 6, 2019

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