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Febuxostat (Gout Medicine) Increases Risk Of Heart Attack

FDA Alerts public to gout medication

December 7, 2017
As of November 15, 2017, the U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. The FDA required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when it approved the drug in 2009. This is not a final result but is significant enough that the public needs to know.

Febuxostat is FDA-approved to treat gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Febuxostat works by lowering uric acid levels in the blood.

The FDA urges that health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. Patients are urged to talk to their health care professionals if they have any questions or concerns. As usual, it is recommended that patients not stop taking the drug without first consulting with their health care professional.

The FDA says that 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 to allopurinol. These problems included heart attacks, strokes, and heart-related deaths. As a result, we 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 that led to the latest warning was conducted in over 6,000 patients with gout. These patients 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.

The FDA is continuing to evaluate this safety issue and will update the public when it has more information. The FDA is urging health care professionals and patients to report side effects involving febuxostat to the FDA MedWatch program.

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