The TGA has strengthened its warning on the use of febuxostat (Adenuric) to include all gout patients with pre-existing major cardiovascular disease.
The PI for the gout drug had previously included a warning that it was not recommended for patients with ischaemic heart disease or congestive heart failure.
However, the TGA says its position has changed in light of new information from the CARES study that found an increased risk of death in gout patients with pre-existing major cardiovascular disease who were treated with febuxostat tablets compared to allopurinol.
A boxed warning has been added to both the febuxostat PI and Consumer Medicine Information (CMI), the TGA stated in a safety advisory.