Febuxostat Cardiovascular Death Warning

[C Noonan]

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!

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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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