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 inf...
FDA - U.S. Food and Drug Administration
Febuxostat Mylan (Active substance: febuxostat) - Centralised - Authorisation - Commission Decision (2017)4267 of Mon, 19 Jun 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/4374
Europe -DG Health and Food Safety