FDA Adds Boxed Warning to Gout Medicine Uloric

February 28, 2019

The U.S. Food and Drug Administration (FDA) has updated the prescribing information for Uloric (febuxostat) to include a boxed warning and an updated patient medication guide after the agency found an increased risk of death associated with the drug. This is the FDA’s strongest possible warning.

Approved in 2009, Uloric is one of only a handful of drugs available to treat gout, a chronic disease affecting about 8.3 million Americans. The FDA is now limiting approval of Uloric for use in patients who are not treated effectively with allopurinol, a safer alternative.

Read the FDA news release.