WASHINGTON, D.C. January 11, 2019 – The U.S. Food and Drug Administration (FDA) should immediately ban the widely used gout medication febuxostat because it poses unique, serious risks – including the risk of dying from cardiovascular disease – and provides no unique benefit, Dr. Michael Carome, director of Public Citizen’s Health Research Group, will tell the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee today. Public Citizen previously petitioned the FDA to ban the medication in June 2018.
The agency convened the advisory committees in response to a request from Takeda Pharmaceuticals America, maker of the brand name febuxostat product Uloric, for approval to update the medication’s labeling to include results of a recently completed randomized clinical trial. The trial, which involved more than 6,000 gout patients, demonstrated that patients receiving febuxostat were significantly more likely to die from cardiovascular causes compared with those receiving the much older gout medication allopurinol.
Initial clinical trials testing febuxostat prior to FDA approval linked the medication to possible increased risks of serious adverse cardiovascular outcomes, including heart attack, stroke and death. The FDA rejected the medication twice over these safety concerns before approving it in 2009 on the condition that the manufacturer conduct the now-completed large, post-market randomized clinical trial to further evaluate the cardiovascular risks.
“Before the FDA approved febuxostat, there was troubling evidence strongly suggesting that the medication increased the risk of serious adverse cardiovascular events and death,” said Carome. “The results of the FDA-mandated post-market trial now provide additional high-quality evidence of a causal link between treatment with febuxostat and an increased risk of death, particularly death from cardiovascular causes.”
Carome will argue that the FDA almost certainly would not have approved febuxostat had data from the postmarket trial been available when the FDA was considering the medication in 2009. Consistent with the precautionary principal of public health, he will urge the committee to recommend that the FDA grant Public Citizen’s petition and remove febuxostat from the market.
Read the testimony (PDF).