According to healthycanadians.gc.ca, a post-market clinical study of the medication ULORIC®(febuxostat)indicates that there is an increased risk of cardiovascular (CV) fatal outcomes in patients with gout who have a history of cardiovascular disease when compared to those who are treated with the drug allopurinol.
Healthcare professionals such as cardiologists, internists, hematologists, rheumatologists, family physicians, general practitioners, nurses, and pharmacists should be aware of this risk.
PreviouslyULORIC® was used to lower serum uric acid levels in patients with gout (as a first-line therapy). As a result of the clinical study, ULORIC® was used for patients who had an inadequate response or intolerance to allopurinol, or for whom treatment with allopurinol was not appropriate (as a second-line therapy).
Healthcare professionals are therefore advised to (i) only use ULORIC® in adult patients who have gout and had an inadequate response to allopurinol or for whom treatment with allopurinol is in appropriate; (ii) not use ULORIC® with those who have ischemic heart disease or congestive heart failure; and (iii) monitor patients taking ULORIC® for signs and symptoms of heart attack, stroke, and cardiac failure.
In the post-market CV clinical study, it reported a higher rate of deadly CV outcomes in patients who were given ULORIC® to treat their gout when compared to those who were treated with allopurinol. In order to mitigate the risks identified in the study, the ULORIC® Canadian Product Monograph 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.
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