AUDIENCE: Health Professional, Patient, Pharmacy
ISSUE: FDA has concluded there is an increased risk of death with febuxostat (Uloric?) 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 febuxostat.
BACKGROUND:Febuxostat 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. Febuxostat 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.1 The number of medicines to treat gout is limited and there is an unmet need for treatments for this disease.
Patients should tell your health care professional if you have a history of heart problems or stroke and discuss the benefits and risks of using febuxostat to treat your gout. Do not stop taking febuxostat without first talking to your health care professional, as doing so can worsen your gout.
Febuxostat is used to treat gout. Gout is a type of arthritis in which uric acid, a naturally occurring substance in the body, builds up in the joints and causes sudden attacks of redness, swelling, pain, and heat in one or more joints. Febuxostat is in a class of medications called xanthine oxidase inhibitors. It works by decreasing the amount of uric acid that is made in the body. Febuxostat is used to prevent gout attacks but not to treat them once they occur.
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