U.S. Food and Drug Administration (FDA) adds a Boxed Warning for added risk of mortality from gout prescription drug Uloric (febuxostat)

U.S. Food and Drug Administration (FDA) adds a Boxed Warning for added risk of mortality from gout prescription drug Uloric (febuxostat)

The U.S. Food and Drug Administration (FDA) just determined that there is an added risk of mortality from Uloric (febuxostat) relative to a competing gout medicine, allopurinol. This conclusion is from an in-depth analysis of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes when using Uloric.


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


Uloric was FDA-approved in 2009 as a treatment for a type of arthritis known as gout in adults. Gout occurs when a naturally occurring substance in the body known as uric acid builds up and creates sudden attacks of redness, and discomfort in one or more joints. Uloric works by reducing uric acid levels in the blood. Gout is a chronic affliction that affects nearly 8.3 million adults in America The amount of medications to treat gout is low and there is a high need for treatments for this disease.


Users should tell their prescribing physician if they have a record of heart issues or stroke and explore the advantages and risks of using Uloric to treat their gout. Seek emergency medical attention immediately if you experience the following symptoms while taking Uloric:


Chest discomfort


Shortness of breath


Rapid or irregular heartbeat


Numbness or weakness on one side of your body




Trouble talking


Sudden extreme headache


Don’t stop taking Uloric without first speaking with your health care professional, as doing so may worsen your gout.


Health care professionals should keep Uloric for use only in patients who have failed or do not tolerate allopurinol. Advise patients about the cardiovascular risk with Uloric and advise them to find medical attention the moment they experience the symptoms listed above.


When the FDA approved Uloric in 2009, they included a Warning and Precaution regarding potential cardiovascular events in patients treated with Uloric in the current prescribing data and required the drug maker, 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. uloric was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and an issue of inadequate blood supply to the heart requiring intervention, called unstable angina.


Does Your Case Qualify for a Lawsuit Against the Makers of Uloric? According to the new Black Box warnings required by the FDA, use of Uloric might increase the risk of suffering one of the following conditions:




Heart Attack




Pulmonary Embolism (PE)


Deep Vein Thrombosis (DVT)


If you or a loved one has experienced any of the above while using 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 experienced as a result of your medical treatment.


The attorneys at The Meneo Law Group not only have the skill, experience, and knowledge to represent your Uloric lawsuit, but a proven history of success in representing people, like you, who have been harmed by dangerous medications and products.



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