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FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

FDA Drug Safety Podcast

FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.

On February 21, 2019 FDA concluded there is an increased risk of death with Uloric (active ingredient febuxostat) compared to another gout medicine, allopurinol. 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 a result, we are updating the Uloric prescribing information to require a Boxed Warning, our most prominent 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.

Uloric was FDA-approved in 2009 to treat gout in adults and works by lowering uric acid levels in the blood. Gout is a chronic disease that affects approximately 8.3 million adults in the U.S. The number of medicines to treat gout is limited and there is an unmet need for treatments for this disease.

When Uloric was approved in 2009, we included a Warning and Precaution regarding possible cardiovascular events in patients treated with Uloric and required the drug manufacturer, Takeda Pharmaceuticals, to conduct a large postmarket safety clinical trial. The trial was conducted 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 unstable angina.

The results showed that overall, Uloric did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, Uloric showed an increased risk of heart-related deaths and death from all causes. This safety trial was also discussed at a public Advisory Committee meeting of outside experts on January 11, 2019.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications.

Health care professionals should reserve Uloric for use only in patients who have failed or do not tolerate allopurinol. Counsel patients about the cardiovascular risk with Uloric and advise them to seek medical attention immediately if they experience symptoms.

Side effects involving Uloric or other medicines should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Infodisclaimer iconfor up to the minute important drug information. Thank you for listening.

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