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.

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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.


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