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

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.