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

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

The U.S. Food and Drug Administration (FDA) has concluded that there is an increased risk of mortality with Uloric (febuxostat) relative to a different gout medication, allopurinol. This conclusion is from an in-depth analysis of results from a safety clinical trial which found an elevated risk of heart-related death and mortality from all causes with Uloric.


Going forward, 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. uloric stroke is also minimizing the accepted consumption of Uloric to certain patients that are not treated well-enough or have severe reactions to from allopurinol.


Uloric was originally FDA-approved in 2009 as a treatment for a type of arthritis referred to as gout in adults. Gout happens when a naturally occurring substance in the body called uric acid aggregates and creates sudden attacks of swelling, and pain in one or several joints. Uloric works by lowering uric acid levels in the blood. Gout is a chronic disease that affects approximately 8.3 million people in America The amount of medications to treat gout is small and there is a high need for treatments for this disease.


Users should contact their health care professional if they have a history of heart problems or stroke and discuss the advantages and risks of using Uloric to treat their gout. Find 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




Trouble talking


Sudden severe headache


Don’t stop taking Uloric before first talking to your health care professional, as doing so may worsen your gout.


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


When the FDA approved Uloric in 2009, they included a Warning and Precaution regarding possible cardiovascular events in patients treated with Uloric in the current prescribing information and mandated the drug manufacturer, Takeda Pharmaceuticals, to perform a large postmarket safety clinical trial. The trial was performed in more than 6,000 patients with gout treated with either Uloric or allopurinol. The primary outcome 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 Manufacturers of Uloric? According to new Black Box warnings required by the FDA, use of Uloric might elevate 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 experienced any of the above while taking Uloric for the treatment of gout, you may be entitled to a settlement from Takeda Pharmaceuticals, as well as for expenses, emotional harm, and inconveniences you have endured as a result of your medical treatment.


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

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