FDA Adds Boxed Warning for Increased Risk of Death for Takeda’s Gout Drug

February 27, 2019

The FDA is requiring that the prescribing information for Takeda’s gout medicine Uloric (febuxostat) include a boxed warning for increased risk of death when compared to another treatment, allopurinol.

The agency reached the decision to require its most prominent warning after an in-depth review of results from a safety clinical trial that showed an increased risk of heart-related death and death from all causes with the drug.

As part of the FDA’s decision, the product will require a new patient medication guide. The agency said it will limit the approved use of Uloric to certain patients who experience side effects or don’t see effective treatment from allopurinol.

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