FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric) (jue, 21 feb 2019)
The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new information.
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FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat) (Thu, 21 Feb 2019)
FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)
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