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20-11-2017 | Rheumatology | News | Article

Regulatory update

FDA announces febuxostat safety alert

medwireNews: The US FDA has issued a safety communication highlighting that febuxostat has been associated with an increased risk for heart-related death compared with allopurinol among patients with gout.

This warning is based on the results of a safety trial of over 6000 patients, which demonstrated that although patients receiving febuxostat did not have a significantly higher risk for the primary cardiac endpoint – a composite of heart-related death, nonfatal myocardial infarction, nonfatal stroke, and cardiac ischemia requiring urgent surgery – than those given allopurinol, febuxostat was associated with an increased risk for all-cause and heart-related mortality.

The current febuxostat label carries a warning for cardiovascular events because clinical trials demonstrated a higher rate of such complications in patients treated with febuxostat compared with allopurinol.

The FDA will conduct a “comprehensive review” when more information is available, and in the meantime it recommends that healthcare professionals “should consider this safety information when deciding whether to prescribe or continue patients on febuxostat.”

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group