Did regulators jump the gun on febuxostat?

Rheumatologists are raising issues with interpretation of the CARES trial

Safety warnings on the increased heart risk posed by gout drug febuxostat are being queried by rheumatologists who have noted that discontinuation of the drug is also associated with excess mortality.


In October, the TGA followed the US FDA in applying a boxed warning to febuxostat, broadening a previous caution against prescribing to patients with ischaemic heart disease or congestive heart failure to include all patients with pre-existing major cardiovascular disease.