New evidence of increased risk of death with Febuxostat (Uloric)

According to the latest CARES trial, the Gout drug Febuxostat (Uloric) failed up against Allopurinol when it came down to a combined rate of fatal and nonfatal adverse events for those that suffer with both Gout and Cardiovascular disease.  In fact, there was a significant increased risk of death for those that took this drug for Gout while also suffering from heart disease.

The trial was mandated by the FDA and consisted of 6,190 patients, 84% of which were men.  Cardiovascular risk is naturally increased in patients with Gout.  The study was attempting to look at any difference in outcome for these patients taking Febuxostat, a nonpurine xanthine oxidase inhibitor, or those taking Allopurinol, a purine base analogue xanthine oxidase inhibitor.  The patients were followed for a median of 32 months, and a maximum of 85 months.  Without diving into all of the ratio statistics, the all-cause and cardiovascular mortality rate was higher in the Febuxostat group, 34% and 22% higher respectively.

Xanthine oxidase inhibitors are designed to block the enzyme that helps your body make uric acid from xanthine.  This sounds great in theory, but begs the question, where do the purines go when they are halted from this natural conversion?  We do know purines can be stored in the fat, but where else might they go?  Although this hasn’t been theoretically proven, it is very common for the liver to become ‘fatty’ while taking this type of drug.  Could those newly developed storages be the “lost” purines?

Common side effects of taking Febuxostat include:

  • nausea
  • joint pain
  • rash
  • inaccurate liver function test results
  • gout flare ups
Call your doctor if these continue or are bothersome:
    • Changes in appetite
    • Constipation or diarrhea
    • Nausea
    • Red, hot flush to face or skin
  • Stomach upset or pain
Call your doctor right away if these occur:
  • Allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • Breathing problems
  • Changes in vision
  • Chest pain
  • Confusion, trouble speaking or understanding
  • Dizziness
  • Fast, irregular heartbeat
  • Feeling faint or lightheaded, falls
  • Gout pain
  • Muscle aches or pains
  • Severe headaches
  • Sudden numbness or weakness of the face, arm or leg
  • Trouble walking, dizziness, loss of balance or coordination
  • Unusually weak or tired
  • Yellowing of the eyes or skin

More serious complications can occur.  As noted above, cardiovascular risks are increased.  In addition to those risks, liver injury is also very possible.  If you have to resort to trying this drug, be sure to have your physician check your liver function before you begin and monitor thereafter.  It is important to know the symptoms and get help immediately.  These warning signs include:

  • Liver injury. Symptoms can include:
    • tiredness
    • lack of appetite
    • unexplained weight loss
    • discomfort in the upper right part of your abdomen
    • dark urine
    • jaundice (yellowing of your skin or the whites of your eyes)
  • Heart attack. Symptoms can include:
    • chest pain
    • shortness of breath
    • discomfort in your upper body
    • cold sweats
    • nausea
    • vomiting
    • sudden dizziness
    • sudden, unexplained tiredness
  • Stroke. Symptoms can include:
    • weakness or numbness in one part or side of your body
    • slurred speech
    • sudden confusion
    • trouble seeing in one or both of your eyes
    • sudden trouble walking, dizziness, or loss of balance or coordination
    • sudden and unexplainable severe headache


5 thoughts on “New evidence of increased risk of death with Febuxostat (Uloric)”

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