26 July 2023


The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently issued updated advice concerning the use of febuxostat in people with a history of cardiovascular disease.

Its previous advice, published in 2019, recommended avoiding treatment with febuxostat in people with pre-existing major cardiovascular disease. Since then, a further randomised trial on the cardiovascular safety of febuxostat, the Febuxostat versus Allopurinol Streamlined Trial (FAST), has been published.

The FAST study was conducted in over 6000 people with gout and at least one cardiovascular risk factor from the UK, Denmark, and Sweden and concluded that febuxostat was non-inferior to allopurinol therapy with respect to the primary cardiovascular endpoint, and, unlike previous trials, that long-term use was not associated with an increased risk of death or cardiovascular death compared with allopurinol.

The updated MHRA guidance advises caution if prescribing febuxostat in patients with pre-existing major cardiovascular disease, particularly, in those with evidence of high urate crystal and tophi burden or those initiating urate-lowering therapy.

For more information on the treatment of gout, read our recent blog and listen to our podcast.