Safety issue alert on gout drug

It is now under review by the TGA

The US Food and Drug Administration (FDA) issued the safety announcement after receiving preliminary results from the CARES (Cardiovascular Safety of Febuxostat and Allopurinol in Patients With Gout and Cardiovascular Comorbidities) trial.


The study involved more than 6000 patients who were randomised to treatment with febuxostat or allopurinol for up to five years. No trial outcomes data has been publicly released.

Febuxostat already has a PI precaution that states it is not recommended for treating patients with ischaemic heart disease or congestive heart failure, following reports of