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FDA Warns of Increased Risk of Death With Gout Medicine Uloric

Posted 22 February 2019 | By Zachary Brennan 

FDA Warns of Increased Risk of Death With Gout Medicine Uloric

The US Food and Drug Administration (FDA) on Thursday said it has concluded there is an increased risk of death with Takeda’s Uloric (febuxostat) when compared to another gout medicine, allopurinol, and the agency added a boxed warning to Uloric.

“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,” FDA said in a safety communication.

When Uloric was first approved in 2009, FDA required Takeda to conduct a large postmarket safety clinical trial in more than 6,000 patients with gout treated with either Uloric or allopurinol. The primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke and a condition of inadequate blood supply to the heart requiring intervention, called unstable angina.

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

In addition, there were 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol. This safety trial was also discussed at a public advisory committee meeting on 11 January.

As a result of the findings, FDA said it is updating the Uloric prescribing information to require a boxed warning and a new patient medication guide.

“We are also limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol,” FDA said.

Safety Announcement

Categories: Regulatory News

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