Concurrent prophylactic treatment w/ NSAID or colchicine is recommended to prevent gout flares during initiation of treatment. Higher rate of CV thromboembolic events (CV deaths, non-fatal MI, & non-fatal strokes); monitor for signs & symptoms of MI & stroke. Obtain a liver test panel (serum ALT, AST, alkaline phosphatase, & total bilirubin) as a baseline before initiating treatment. Interrupt treatment if the patient is found to have abnormal liver tests (ALT >3x the upper limit of the reference range); do not restart in patients w/o another explanation for the liver test abnormalities. Risk for severe drug induced liver injury w/ elevations of serum ALT (>3x) or bilirubin (>2x). Secondary hyperuricemia (including organ transplant recipients). Not recommended for use in patients w/ increased rate of urate formation (eg, malignant disease & its treatment, Lesch-Nyhan syndrome). Severe hepatic impairment (Child Pugh class C). Pregnancy & lactation. Childn <18 yr.