Drug Safety Alerts

Uloric® (febuxostat) Black Box Warning

02/21/2019

On February 21, 2019, the United States Food and Drug Administration (FDA) issued a MedWatch to announce there is an increased risk of death with Uloric^® (febuxostat) compared to another gout medicine, allopurinol. This conclusion is based on the FDA’s 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.

As a result, the FDA is updating the Uloric prescribing information to require a Boxed Warning, their most prominent warning, and a new patient Medication Guide. The FDA is also limiting the approved use of Uloric 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. Gout is a chronic disease that affects approximately 8.3 million adults in the U.S. The number of medicines to treat gout is limited and there is an unmet need for treatments for this disease.

The FDA recommends that patients should tell their health care professional if they have a history of heart problems or stroke and discuss the benefits and risks of using Uloric to treat their gout. Patients should not stop taking Uloric without first talking to their health care professional, as doing so can worsen their gout. Patients should seek emergency medical attention right away if they 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

The FDA recommends that health care professionals should reserve Uloric for use only in patients who have failed or do not tolerate allopurinol. The FDA also recommends that health care professionals should counsel patients about the cardiovascular risk with Uloric and advise them to seek medical attention immediately if they experience the symptoms listed above.

CVS Caremark Response: There have been no recalls issued on Uloric. CVS Caremark Mail Service Pharmacy will continue to dispense this product.

For more information about this, health care providers may contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.