FDA Adds Boxed Warning for Uloric

Submitted by Joshua Dakon, PharmD, BPCS, Augusta Health Pharmacy Operations Coordinator

On February 21st, 2019, the U.S. Food and Drug Administration (FDA) announced a new Boxed Warning for Uloric® (febuxostat), a medication used to treat gout. In a large, multicenter post marketing safety trial, Uloric showed an increased risk of cardiovascular-related deaths and death from all causes when compared to allopurinol. The Augusta Health Pharmacy & Therapeutics Committee has reviewed this information and has requested that the FDA’s Safety Communication be forwarded to all providers. Febuxostat will remain on the hospital’s medication formulary for patients not treated effectively or who experience severe side effects with allopurinol or who are managed on febuxostat as an outpatient.
At your earliest convenience, please review the safety communication: Uloric Safety Communication