BRIEF—FDA issues preliminary warning over Uloric results

The US FDA says early results from a safety clinical trial, which it mandated Japanese drugmaker Takeda carry out, show an elevated risk of heart-related death with Uloric (febuxostat), compared to allopurinol.

Uloric has carried a warning and precaution about cardiovascular events since its approval in 2009, due to trials showing a higher rate of heart-related problems, including heart attacks, strokes, and heart-related deaths.

The primary outcome of the trial was a combination of these conditions, and preliminary results show that overall, Uloric did not increase the risk of these combined events.

However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.