FDA Adds Boxed Warning About CV Risks to Gout Drug Febuxostat

Six weeks after hosting a joint meeting of its Arthritis Advisory and Drug Safety and Risk Management Advisory Committees to review cardiovascular risk signals, the US Food and Drug Administration has announced it is adding a new boxed warning to febuxostat (Uloric; Takeda).

“FDA has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol,” reads an announcement issued yesterday. “This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric.”

As reported by TCTMD, 19 out of 22 advisory panel members voted that there is a population of gout patients for whom the risk-benefit profile is favorable with febuxostat for the treatment of hyperuricemia, with several recommending a boxed warning on the label. Other options under consideration by the panel included the removal of the drug from the market or the creation of a risk evaluation and mitigation strategy (REMS) to control access to the agent.

Concerns about the drug stemmed from a signal of increased cardiovascular deaths among patients taking febuxostat in the CARES postmarketing study, released last year, as reported by TCTMD.

In its announcement today, FDA recommends that health professionals reserve use of the drug for patients “who have failed or do not tolerate allopurinol” and to counsel patients about the cardiovascular risks of the agent.

Patients, likewise, “should tell your healthcare professional if you have a history of heart problems or stroke and discuss the benefits and risks of using Uloric to treat your gout,” but should not stop taking the drug without first discussing next steps with their doctors.