FDA: Higher death risk with this gout drug

February 25, 2019

FDA is requiring the addition of a Black Box Warning to a gout drug that has an increased risk of death.

FDA is requiring the addition of a Black Box Warning to a gout drug that has an increased risk of death.

FDA said there is an increased risk of death with febuxostat (Uloric, Takeda) compared to another gout medicine, allopurinol (Zyloprim and Aloprim, DSM Pharmaceuticals & Prometheus, Mylan).

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“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,” the agency said in a Medwatch warning.

Uloric was FDA-approved in 2009 to treat a type of gout in adults. While gout affects approximately 8.3 million adults in the United States, the number of medicines to treat the chronic condition is limited, and there is an unmet need for treatments for the disease, FDA said.

Healthcare professionals should reserve Uloric for use only in patients who have failed or do not tolerate allopurinol, the agency said. “Counsel patients about the cardiovascular risk with Uloric and advise them to seek medical attention immediately if they experience the symptoms listed above,” FDA said.

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Symptoms include: chest pain, shortness of breath, rapid or irregular heartbeat, numbness on one side of the body, dizziness, trouble talking, and sudden severe headache.

Patients should tell their healthcare professional if they have a history of heart problems or stroke and discuss the benefits and risks of using Uloric to treat gout. “Do not stop taking Uloric without first talking to your health care professional, as doing so can worsen your gout,” FDA said.

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