U.S. Food and Drug Administration (FDA) has issued Boxed Warning for increased risk of mortality with gout prescription drug Uloric (febuxostat)

U.S. Food and Drug Administration (FDA) has issued Boxed Warning for increased risk of mortality with gout prescription drug Uloric (febuxostat)

The U.S. Food and Drug Administration (FDA) has determined there is an increased risk of death with Uloric (febuxostat) relative to a competing gout medicine, allopurinol. The conclusion is based on our in-depth study of results from a safety clinical trial that found an elevated risk of heart-related death and death from all causes with Uloric.


As a result, the FDA has mandated the updating of the Uloric prescribing information to require a Boxed Warning, the highest priority warning, and a new patient Medication Guide. The FDA is also limiting the approved consumption of Uloric to certain patients who are not treated effectively or experience significant side effects with allopurinol.


Uloric was originally FDA-approved in 2009 as a treatment for a type of arthritis referred to as gout in adults. Gout occurs when a naturally occurring substance in the body called uric acid scales up and causes sudden attacks of redness, and discomfort in one or more joints. Uloric works by reducing uric acid amounts in the blood. Gout is a chronic affliction that affects approximately 8.3 million adults in the U.S. The number of medicines to treat gout is small and there is a high need for medications for this disease.


Patients should tell their health care professional if they have a history of heart problems or stroke and explore the advantages and risks of using Uloric to treat their gout. Seek emergency medical attention right away if you experience the following symptoms while taking Uloric:


Chest discomfort


Shortness of breath


Rapid or irregular pulse


Numbness or weakness on one side of your body




Difficulty talking


Sudden extreme headache


Don’t stop taking Uloric before first speaking with your health care professional, as doing so might worsen your gout.


Health care professionals should reserve Uloric for use only for patients who have failed or do not tolerate allopurinol. Counsel patients regarding the cardiovascular risk with Uloric and advise them to find medical attention immediately if they experience the symptoms listed above.


When the FDA approved Uloric in 2009, they added a Warning and Precaution regarding possible cardiovascular events in patients treated with Uloric in the current prescribing data and required the drug manufacturer, Takeda Pharmaceuticals, to perform a large postmarket safety clinical trial. The trial was conducted in more than 6,000 patients with gout treated with either Uloric or allopurinol. The primary result was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and an issue of insufficient blood supply to the heart requiring intervention, called unstable angina.


Does Your Case Qualify for an Action Against the Makers of Uloric? According to the new Black Box warnings mandated by the FDA, use of Uloric can increase the chances of suffering one of the following side-effects:




Heart Attack




Pulmonary Embolism (PE)


Deep Vein Thrombosis (DVT)


If you or a loved one has suffered any of the above while taking Uloric for the condition of gout, you may be entitled to a settlement from Takeda Pharmaceuticals, as well as for any expenses, emotional harm, and inconveniences you have endured as a result of your medical treatment.


uloric lawsuit at The Meneo Law Group not only have the ability, experience, and expertise to represent your Uloric lawsuit, but a proven track record of success in representing people, like you, who have been harmed by dangerous drugs and products.