Blow for Takeda's Uloric as US FDA adds new safety warning
Following consideration of a post-marketing study, conducted as a condition of its 2009 approval, the US regulator has added a Boxed Warning to the label for gout therapy Uloric (febuxostat).
The US Food and Drug Administration says the study shows there is an increased risk of death with Uloric, compared to rival gout medicine allopurinol.
The safety clinical trial, conducted by the drug’s manufacturer Takeda Pharmaceutical (TYO: 4502), showed an increased risk of heart-related death and death from all causes with Uloric.
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