Uloric Labeling Updated With New Indication, Boxed Warning After Review of CV Safety Data

The prescribing information for Uloric (febuxostat; Takeda) is being updated to include a Boxed Warning regarding an increased risk of cardiovascular (CV) death and all-cause mortality in patients treated with the gout drug. In addition, the Food and Drug Administration (FDA) is limiting the approved use of Uloric, reserving the drug for patients who have failed or cannot tolerate maximally titrated allopurinol doses.

Febuxostat, a xanthine oxidase inhibitor, was initially approved in 2009 for the chronic management of hyperuricemia in patients with gout. In November 2017, the FDA had issued a safety communication warning the public that preliminary results from the CARES (Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities) trial (N=6190) assessing the safety of febuxostat showed an increased risk of CV-related death compared with allopurinol.

After an in-depth review of the study results, the FDA has concluded that while the study met the pre-specified noninferiority margin, a significant increase in cardiovascular death (hazard ratio [HR] 1.34, 95% CI 1.03, 1.73) and all-cause mortality (HR 1.22, 95% CI 1.01, 1.47) was observed with febuxostat when compared with allopurinol.

Based on these findings, the FDA recommends that healthcare professionals monitor Uloric-treated patients for cardiovascular signs and symptoms and counsel them on when to seek immediate medical attention. In addition, a new Medication Guide, which discusses the cardiovascular risks, should be provided to patients who receive Uloric prescriptions.

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For more information visit FDA.gov.