Uloric (febuxostat): Boxed Warning Added - Due to Increased Risk of Death with Gout Medicine

AUDIENCE: Health Professional, Patient, Pharmacy

ISSUE: FDA has concluded there is an increased risk of death with Uloric (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.

BACKGROUND: 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. 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.

RECOMMENDATION:

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 Uloric to treat your gout. Do not stop taking Uloric without first talking to your health care professional, as doing so can worsen your gout. Seek emergency medical attention right away if you experience the following symptoms while taking Uloric:

• Chest pain
• Shortness of breath
• Rapid or irregular heartbeat
• Numbness or weakness on one side of your body
• Dizziness
• Trouble talking
• Sudden severe headache

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 the symptoms listed above.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
 

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[02/21/2019 - Drug Safety Communication - FDA]