The TGA has slapped a boxed warning on the gout drug febuxostat following concern over an increased risk of death in patients who have major cardiovascular disease.

This follows a US study last year of more than 6000 patients with gout and CVD, which found all-cause and cardiovascular mortality were higher among those taking febuxostat compared with the first-line urate-lowering medication allopurinol.

In a safety advisory last week, the TGA said the product information for febuxostat (Adenuric) previously warned against its use in patients with ischaemic heart disease or congestive heart failure, but this had been strengthened to include all patients with pre-existing major cardiovascular disease.

Meanwhile, an unrelated study published in the CMAJ raised concerns about severe cutaneous adverse reactions associated with high-dose initiation of allopurinol in patients with cardiac conditions.