FDA Adds Boxed Warning to Gout Drug

By Amy Orciari Herman

Edited by André Sofair, MD, MPH

The FDA has mandated that the gout drug febuxostat (Uloric) carry a boxed warning to alert clinicians and patients to the increased risk for cardiovascular (CV) death with the drug. The warning also states that febuxostat use should be limited to patients who do not respond to or cannot tolerate allopurinol.

The warning follows results from a postmarketing randomized trial comparing febuxostat with allopurinol in some 6000 patients with gout and CV disease: there were 15 CV deaths for every 1000 patients treated with febuxostat for 1 year, versus 11 for every 1000 treated with allopurinol. For all-cause mortality, the numbers were 26 deaths per 1000 treated with febuxostat, versus 22 per 1000 with allopurinol.

Clinicians should educate patients about the CV risk with febuxostat, the FDA says, and they should advise patients to seek medical attention right away if they experience symptoms like chest pain, shortness of breath, and irregular heartbeat while taking the drug.