RT Book, Section A1 Fravel, Michelle A. A1 Ernst, Michael E. A2 DiPiro, Joseph T. A2 Talbert, Robert L. A2 Yee, Gary C. A2 Matzke, Gary R. A2 Wells, Barbara G. A2 Posey, L. Michael SR Print(0) ID 1164577366 T1 Gout and Hyperuricemia T2 Pharmacotherapy: A Pathophysiologic Approach, 10e YR 2017 FD 2017 PB McGraw-Hill Education PP New York, NY SN 9781259587481 LK accesspharmacy.mhmedical.com/content.aspx?aid=1164577366 RD 2024/04/24 AB Content UpdateAugust 7, 2019FDA Warns of Increased Risk of Death with Febuxostat in Patients with Gout and Cardiovascular Disease: In February 2019, the U.S. Food and Drug Administration issued a new boxed warning and Medication Guide for febuxostat (Uloric), a xanthine oxidase inhibitor used to lower serum uric acid concentrations in patients with gout. In a randomized controlled study (the CARES trial), febuxostat was associated with an increased risk of cardiovascular death and death from any cause when compared with allopurinol. Based on the labeling change, febuxostat should only be prescribed for patients who have had an inadequate response, intolerance, or contraindications to allopurinol. Patients should be informed of the potential for adverse cardiovascular events and advised to notify their healthcare provider if cardiovascular symptoms occur.