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.
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