Medication Monitor

Generic Name (Trade Name—Company)
November 21, 2017


FDA evaluating increased risk of death with use of gout medication

FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat compared with allopurinol, another gout medication. FDA required febuxostat's manufacturer, Takeda, to conduct this safety study when FDA approved the medicine in 2009. 

Febuxostat is FDA-approved to treat gout in adults and works by lowering uric acid levels in the blood.

Health professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. Patients should not stop taking the medication without first consulting their health provider.

The febuxostat drug labels already carry a warning and precaution about cardiovascular events because the clinical trials conducted before approval showed a higher rate of heart-related problems in patients treated with febuxostat compared with allopurinol. These problems included heart attacks, strokes, and heart-related deaths. As a result, FDA required an additional safety clinical trial after the drug was approved and on the market to better understand these differences, and that trial was finished recently.

The safety trial was conducted in more than 6,000 patients with gout treated with either febuxostat or allopurinol. The primary outcome was a combination of heart-related death, nondeadly heart attack, nondeadly stroke, and a condition of inadequate blood supply to the heart that requires urgent surgery.

Preliminary results showed that overall, febuxostat did not increase the risk of these combined events compared with allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.

Once FDA receives the final results, the agency will conduct a comprehensive review and update the public with any new information.