Febuxostat: Increased Risk of Mortality

Drug Safety Update

In 2009, febuxostat (non-purine selective xanthine oxidase inhibitor) was approved by US Food and Drug Administration (FDA) to treat gout, but with a warning and precaution regarding possible cardiovascular events. The manufacturer was required to conduct a large post-marketing safety clinical trial.

Since its launch, rare but serious reports of hypersensitivity reactions, including Stevens-Johnson syndrome and acute anaphylactic shock, have been reported with febuxostat.

  • Most cases occur during the first month of treatment. If these occur, febuxostat must be stopped immediately and must not be restarted.

The double-blind study (CARES) compared cardiovascular outcomes in patients with gout and major cardiovascular disease (n = 6198) who were randomised to febuxostat or to allopurinol.
  • Treatment groups did not differ with respect to a primary composite outcome of cardiovascular events.
  • However, cardiovascular death and all-cause mortality were significantly more common among patients taking febuxostat than allopurinol (4.3% vs. 3.2%, HR 1.34 [95% CI 1.03 to 1.73]; 7.8% vs. 6.4%, HR 1.22 [95% CI 1.01 to 1.47], respectively).



Recommendations

Consequently, healthcare professionals are advised by FDA to
  • Prescribe febuxostat only for patients who have failed treatment with or cannot tolerate allopurinol.
  • Counsel patients regarding the cardiovascular risk with febuxostat and advise them to seek medical attention immediately if they experience chest pain, shortness of breath, rapid or irregular heartbeat, numbness or weakness on one side of their body, dizziness, trouble speaking, or sudden severe headache.



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