FDA warns of increased risk of death with Uloric gout drug

The US Food and Drug Administration (FDA) announced Thursday that it has found an increased risk of death by Takeda's Uloric (febuxostat) compared to another drug against gout, allopurinol, and added a boxed warning at Uloric.

"This conclusion is based on our extensive review of the results of a clinical safety trial that revealed an increased risk of cardiac death and death from all causes with Uloric," the FDA said. in a communication on the safety.

When Uloric was first approved in 2009, the FDA asked Takeda to conduct a large post-marketing safety trial in more than 6,000 gout patients treated with Uloric or Allopurinol. The main result was a combination of deaths from heart-related, non-fatal heart attack, non-fatal stroke and a state of inadequate blood supply. in the heart requiring intervention, called unstable angina pectoris.

The results of the trial showed that, overall, Uloric did not increase the risk of these combined events compared with allopurinol. But when the results were evaluated separately, in patients treated with Uloric, 15 deaths for heart-related causes were observed per 1,000 patients treated for one year, compared with 11 deaths for heart-related cases per 1,000 treated patients. with allopurinol for one year.

In addition, there were 26 all-cause deaths per 1,000 patients treated with Uloric for one year, compared to 22 deaths per 1,000 patients treated for one year with allopurinol. This security test was also discussed at a public advisory committee meeting on January 11th.

As a result of these findings, the FDA announced that it was updating Uloric's prescribing information to require boxed warning and a new medication guide for the patient.

"We also limit the approved use of Uloric to certain patients who are not effectively treated or who are experiencing serious side effects with allopurinol," the FDA said.

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