Uloric Warning for Cardiovascular Death

Febuxostat Cardiovascular Death Warning

Stopping Gout Together Forums Help My Gout! The Gout Forum Febuxostat Cardiovascular Death Warning

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    • #9014
      C Noonan
      Participant


      Are you aware that in Feb of this year, 2019, the FDA announced a “Black Box Warning” for Febuxostat? It is in relation to high risk warnings of heart attack, stroke and death!


      Uloric Warning for Cardiovascular Death

      Uloric Warning for Cardiovascular Death

      The warning reads:

      Highlights of the Prescribing Information

      These highlights do not include all the information needed to use Uloric safely and effectively. See full prescribing information for Uloric.

      Uloric (febuxostat) tablets, for oral use
      Initial U.S. Approval 2009

      Warning: Cardiovascular Death

      See full prescribing information for complete board warning.

      • Gout patients with established cardiovascular (CV) disease treated with Uloric had a higher rte of CV death compared to those treated with allopurinol in a CV outcomes study.
      • Consider the risks and benefits of Uloric when deciding to prescribe or continue patients on Uloric. Uloric should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.
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