Gout Rx Under FDA Investigation

Febuxostat (Uloric) may pose risk of heart-related death, according to FDA

(RxWiki News) The US Food and Drug Administration (FDA) has issued a new warning for a common gout medication.

According to preliminary results from a safety clinical trial, febuxostat (Uloric), when compared to allopurinol, may pose an increased risk of heart-related death.

Both febuxostat and allopurinol are commonly prescribed for the treatment of gouty arthritis, a condition marked by the buildup of uric acid. The condition results in redness, swelling, and pain in one or more joints. Febuxostat works to treat gout by lowering uric acid levels in the blood.

Before febuxostat was approved, data from clinical trials showed an increased rate of heart-related problems. These problems included heart attacks, strokes and heart-related deaths. As a result, the medication carries a warning about possible heart events.

In addition, the FDA required the drug manufacturer to conduct an additional safety clinical trial after the drug was approved. That trial finished recently. During this safety trial, over 6,000 study participants were treated with either febuxostat or allopurinol.

Overall, the preliminary results showed that, when compared to allopurinol, febuxostat did not appear to increase the risk of heart-related death, non-deadly heart attack, non-deadly stroke and a condition marked by inadequate blood supply to the heart. However, when the possible outcomes were evaluated separately, febuxostat was tied to an increased risk of heart-related deaths and death from all causes when compared to allopurinol, according to the FDA.

The FDA said it will provide a comprehensive review when it receives final results from Takeda Pharmaceuticals, the manufacturer of Uloric.

Talk to your health care provider if you have any questions or concerns. Do not stop taking your medicine without first speaking with your doctor.

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Review Date: 
November 27, 2017