Dear Doctor Letter (Rote-Hand-Brief) on Adenuric® (febuxostat): increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study
2019.06.27
Active substance: Febuxostat
The marketing authorisation holder of febuxostat containing medicines in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you, that in a phase IV clinical study (the CARES study) in patients with gout and a history of major cardiovascular (CV) disease, a significantly higher risk for all-cause mortality and for CV-related death was observed in patients treated with febuxostat compared with patients treated with allopurinol. Treatment with febuxostat in patients with pre-existing major CV disease (e.g. myocardial infarction, stroke or unstable angina) should be avoided, unless no other therapy options are appropriate.
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