Preliminary results from a clinical trial show that patients taking the gout medication febuxostat (brand name Uloric) were at greater risk of heart-related death than patients taking another gout medication called allopurinol, the Food and Drug Administration (FDA) announced in a safety communication.
The agency had ordered Uloric’s maker, Takeda Pharmaceuticals, to conduct a safety study when the medication was approved in 2009 to better understand its risks. The agency is still evaluating the data and will update the public once the final results are available from Takeda and a comprehensive review is conducted.
Febuxostat already carries a warning about cardiovascular events based on clinical trials before the medication was approved that showed a higher rate of heart-related problems in patients taking febuxostat compared to allopurinol. These problems included heart attacks, strokes, and heart-related deaths.
Because of that, the FDA required an additional safety clinical trial after the drug was approved and on the market to get a better understanding of these risks. The trial was recently finished.
The safety trial involved more than 6,000 patients with gout who were treated with either febuxostat or allopurinol. Researchers noted heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery.
Preliminary results showed that overall, febuxostat did not increase the risk of these combined events compared to allopurinol. But 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 data and will update the public when it has more information. In the interim, health care providers and patients are urged to report any side effects or adverse events with febuxostat to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Safety Communication