The FDA has issued an alert concerning febuxostat (Uloric, Takeda Pharmaceuticals), a drug for gout. A clinical trial has shown that febuxostat has an increased risk of heart-related deaths compared to allopurinol.
Labeling for febuxostat already carries a warning and precaution about cardiovascular events because preapproval clinical trials showed a higher rate of heart-related problems—including heart attacks, strokes, and heart-related deaths—compared to allopurinol. Because of this, the FDA required that Takeda conduct a safety clinical trial after the drug was on the market.
The postapproval trial has concluded and once final results are received, the FDA will conduct a comprehensive review and update the public with any new information. This trial involved more than 6,000 patients with gout who were treated with either febuxostat or allopurinol.
“The primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery. The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes,” according to an FDA statement.
The FDA is recommending that health-care professionals consider this safety information when deciding whether to prescribe febuxostat for patients with gout or continue them on it. Patients should be instructed not to stop taking the medication without talking with their health-care provider.