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Gout Flare: After initiation of Febuxostat, an increase in gout flares is frequently observed. This increase is due to reduction in serum uric acid levels resulting in mobilization of urate from tissue deposits.
In order to prevent gout flares when Febuxostat is initiated, concurrent prophylactic treatment with an NSAID or colchicine is recommended.
Cardiovascular Events: In the randomized controlled studies, there was a higher rate of cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) in patients treated with Febuxostat [0.74 per 100 P-Y (95% Cl 0.36-1.37)] than allopurinol [0.60 per 100 P-Y (95% Cl 0.16-1.53)]. A causal relationship with Febuxostat has not been established. Monitor for signs and symptoms of myocardial infarction (MI) and stroke.
Liver Enzyme Elevations: During randomized controlled studies, transaminase elevations greater than 3 times the upper limit of normal (ULN) were observed (AST: 2%, 2%, and ALT: 3%, 2% in Febuxostat and allopurinol-treated patients, respectively). No dose-effect relationship for these transaminase elevations was noted. Laboratory assessment of liver function is recommended at, for example, 2 and 4 months following initiation of Febuxostat and periodically thereafter.
Effects on Ability to Drive and Use Machines: Somnolence, dizziness, paraesthesia and blurred vision have been reported with the use of Febuxostat. Patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that Febuxostat does not adversely affect performance.
