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Content Update

August 7, 2019

FDA Warns of Increased Risk of Death with Febuxostat in Patients with Gout and Cardiovascular Disease: In February 2019, the U.S. Food and Drug Administration issued a new boxed warning and Medication Guide for febuxostat (Uloric), a xanthine oxidase inhibitor used to lower serum uric acid concentrations in patients with gout. In a randomized controlled study (the CARES trial), febuxostat was associated with an increased risk of cardiovascular death and death from any cause when compared with allopurinol. Based on the labeling change, febuxostat should only be prescribed for patients who have had an inadequate response, intolerance, or contraindications to allopurinol. Patients should be informed of the potential for adverse cardiovascular events and advised to notify their healthcare provider if cardiovascular symptoms occur.



Upon completion of the chapter, the reader will be able to:

  1. Explain the pathophysiologic mechanisms underlying gout and hyperuricemia.

  2. Recognize major risk factors for developing gout in a given person.

  3. Assess the signs and symptoms of an acute gout attack.

  4. List the treatment goals for a patient with gout.

  5. Develop a pharmacotherapeutic plan for a patient with acute gouty arthritis that includes individualized drug selection and monitoring for efficacy and safety.

  6. Identify patients for whom prophylactic urate-lowering therapy for gout and hyperuricemia is warranted.

  7. Formulate appropriate educational information for a patient on lifestyle modifications to help prevent gouty arthritis attacks.

  8. Select an appropriate drug to reduce serum uric acid (SUA) levels in patients with gout, and outline a plan for monitoring efficacy and toxicity.


image Gout is an inflammatory condition of the arthritis-type that results from deposition of uric acid crystals in joint spaces or surrounding tissues, leading to an inflammatory reaction that causes intense pain, erythema, and joint swelling. It is associated with hyperuricemia, defined as a SUA level of 6.8 mg/dL (404 μmol/L) or greater, but not all patients with hyperuricemia demonstrate symptoms.1 Four organizations publish guidelines that provide recommendations for the diagnosis and/or management of gout.2-9 There is much similarity in the recommendations, and this chapter focuses primarily on the consensus expert panel recommendations of the American College of Rheumatology (ACR).5,6 However, the American College of Physicians (ACP) guideline includes updated clinical trial data and some distinct and controversial differences.8-10


Gout is the most common inflammatory arthritis in men, with a male:female incidence of about 4:1; it affects over 3% of US adults.1,11 The National Health and Nutrition Examination Survey (NHANES) 2007–2008 estimated the prevalence of gout among US adults to be 8.3 million.12 The incidence increases with age and is rising in part due to a larger number of patients with risk factors for gout.13...

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