February 2019

FDA Adds Boxed Warning to Uloric

The U.S. Food and Drug Administration (FDA) has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. This conclusion is based on its 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, updated Uloric prescribing information now carries a Black Box Warning, FDA’s most prominent warning, and a new patient Medication Guide. FDA-approved use of Uloric is now limited to certain patients who are not treated effectively or experience severe side effects with allopurinol.

Uloric was FDA-approved in 2009 to treat a type of arthritis called gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Uloric works by lowering uric acid levels in the blood.

FDA advises healthcare professionals to reserve Uloric for use only in patients who have failed or do not tolerate allopurinol and to counsel patients about the cardiovascular risk with Uloric and advise them to seek medical attention immediately if they experience any cardiovascular symptoms (eg, chest pain, shortness of breath, rapid or irregular heartbeat).

While FDA’s 2009 approval of Uloric included a Warning and Precaution regarding possible cardiovascular events in patients treated with Uloric, the drug manufacturer, Takeda Pharmaceuticals, was required 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 a condition of inadequate blood supply to the heart requiring intervention, called 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. 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.

Source: FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat). Available at https://www.fda.gov/Drugs/DrugSafety/ucm631182.htm

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