Gout Drug Febuxostat (Uloric) Subject of FDA Safety Alert

Megan Brooks


November 15, 2017

Preliminary results from a safety study show an increased risk for heart-related death with the gout medication febuxostat (Uloric, Takeda Pharmaceuticals) compared with another gout medicine, allopurinol, the US Food and Drug Administration (FDA) said today in a safety communication.

The FDA required Takeda Pharmaceuticals to conduct the safety study when febuxostat was approved in 2009. The agency said that trial was recently completed, and once they receive final results from the company they will conduct a comprehensive review and update the public with any new information.

Currently, the febuxostat drug label includes a warning and precaution about cardiovascular events due to a higher rate of heart-related problems, including myocardial infarction (MI), stroke, and heart-related death, in patients treated with febuxostat compared with those receiving allopurinol in preapproval clinical trials, the FDA said.

The FDA-required safety trial included more than 6000 patients with gout treated with febuxostat or allopurinol. The primary outcome was a combination of heart-related death, nonfatal MI, nonfatal stroke, and cardiac ischemia 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 said.

Until more information is available, the FDA advises health providers to "consider this safety information when deciding whether to prescribe or continue patients on febuxostat."

Febuxostat was flagged in the FDA's drug "watch list" in July for possible drug reaction with eosinophilia and systemic symptoms. The watch list reflects potential signals of serious risk or new safety information gathered by the FDA Adverse Event Reporting System (FAERS).  

Adverse events or side effects related to the use febuxostat should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.  

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