FEBURIC® (febuxostat): Increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study

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Febuxostat is a non-purine selective inhibitor of xanthine oxidase that reduces the formation of uric acid. It is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).


The Phase IV CARES (Cardiovascular safety of febuxostat and allopurinol in patients with gout and cardiovascular comorbidities) study was a multicentre, randomised, double-blind, non-inferiority trial performed in the United States of America, Canada and Mexico to evaluate the cardiovascular safety of febuxostat and allopurinol in subjects with gout and major cardiovascular comorbidities. More than 6,000 patients were recruited to compare cardiovascular outcomes with febuxostat (n=3,098) versus allopurinol (n=3,092). The main outcomes of the study are: 

  • Higher all-cause mortality and cardiovascular-related death were observed in patients treated with febuxostat compared with patients treated with allopurinol.
  • For patients with pre-existing major cardiovascular disease, treatment with febuxostat should be avoided unless no other therapy options are appropriate.


NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Astellas Pharma Malaysia Sdn. Bhd. to highlight this safety issue. The product package insert is being updated to reflect this new information. For further information, please contact your local sales person for a copy of the DHPC.

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400



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