FDA/CDC

FDA: Febuxostat may have increased heart-related death risk


 

The urate-lowering therapy febuxostat may have a higher risk of heart-related death than does another urate-lowering drug, allopurinol, according to a Safety Alert from the Food and Drug Administration.

FDA icon Wikimedia Commons/FitzColinGerald/Creative Commons License
In preliminary results from a safety trial of over 6,000 gout patients with a primary outcome of heart-related death, nondeadly heart attack, nondeadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery, febuxostat (Uloric) did not differ significantly from allopurinol. However, when each outcome was analyzed separately, heart-related death and death from all causes were higher in patients receiving febuxostat.

The safety trial was commissioned after febuxostat was approved by the FDA in 2009. Clinical trials conducted pre-approval showed an increased risk of heart-related problems, compared with allopurinol, and the drug label already carries a warning about cardiovascular events.

“Once the final results from the manufacturer are received, the FDA will conduct a comprehensive review and will update the public with any new information,” the agency said in the Safety Alert.

lfranki@frontlinemedcom.com

Recommended Reading

Colchicine Halved MI Risk in Gout
MDedge Cardiology
Gout Prevalence Has Spiked
MDedge Cardiology
Old gout drug learns new cardiac tricks
MDedge Cardiology
Tight inflammation control could reduce CV risk in men with gout
MDedge Cardiology
Colchicine may provide potent cardiac protection
MDedge Cardiology
COPPS-2 curtails colchicine enthusiasm in cardiac surgery
MDedge Cardiology
Gout increases risk of vascular disease, especially for women
MDedge Cardiology
Allopurinol and ventricular arrhythmias: Is there a link?
MDedge Cardiology

Related Articles