FDA issues safety alert on gout drug

A renewed cardiovascular  alert has been issued on the gout drug febuxostat (Adenuric) after a safety study showed an increased risk of patient deaths compared with use of allopurinol.

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