FDA Adds 'Increased Risk of Death' Boxed Warning to Gout Drug Uloric

WASHINGTON, D.C. — The Food and Drug Administration has ordered the makers of Uloric (febuxostat) to add a boxed warning concerning an increased risk of death with the prescription gout drug as compared to a different medicine, allopurinol.

In a Feb. 21 alert, the agency explained that its conclusion is based upon its in-depth review of results from a safety clinical trial conducted by the drug’s manufacturer, Takeda Pharmaceutical, which found an increased risk of heart-related death and death from all causes with Uloric.

“Health care professionals should reserve Uloric for use only in patients who have failed or do …