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FDA Warns of Increased Risk of Death with Gout Medicine Uloric

March 6, 2019
The agency is updating the drug's prescribing information to require a Boxed Warning and a new patient Medication Guide.

FDA recently issued1 a boxed-warning for Uloric (febuxostat). Uloric was approved by the FDA in 2009 to treat gout, a type of arthritis in adults. Uloric’s mechanism of action lowers uric acid levels in the blood. Increased uric acid levels in the blood result in symptoms of redness, swelling and pain commonly associated with gout.

The FDA warns that Uloric leads to an increased risk of death, compared to allopurinol, another medicine to treat gout. This conclusion was made after a comprehensive review of results from a safety clinical trial found an increased risk of heart-related death and death from all causes with Uloric.

The agency will be limiting the approved use of Uloric to those not treated effectively or who experience severe side effects with allopurinol. (Source: 123RF)

Health care professionals should be cautious in prescribing Uloric. Asking a patient of any history of heart attack or stroke should be included in assessing for the appropriate medication. Side effects of Uloric include:

  • Chest pain
  • Shortness of breath
  • Rapid or irregular heartbeat
  • Numbness of weakness on one side of the body
  • Dizziness
  • Trouble talking
  • Sudden severe headache

The FDA recommends Uloric be reserved for patients who have failed or do not tolerate allopurinol. It is essential for a physician’s consultation to include the cardiovascular risk associated with Uloric.

-Reporting by Cornelius Muntazar

Last updated on: April 15, 2019
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