November 4, 2019

Results from a post-market clinical study (the CARES trial)1 found an increased risk of cardiovascular (CV) fatal outcomes in patients with gout and known cardiovascular disease treated with ULORIC, when compared to those treated with allopurinol (see Background section for more details). Healthcare professionals are advised to: Use ULORIC only in adult patients with gout who have an inadequate response or intolerance to allopurinol, or for whom treatment with allopurinol is inappropriate (second line therapy). Not recommend ULORIC treatment in patients with ischemic heart disease or congestive heart failure.

Monitor for signs and symptoms of myocardial infarction, stroke and cardiac failure in patients who are taking ULORIC. The Canadian Product Monograph (CPM) for ULORIC has been updated to include a revised indication for use and safety information, including a new Serious Warnings and Precautions Box with regards to increased risk of cardiovascular death.