US Food and Drug Administration FDA has issued Boxed Warning due to enhanced risk of death with gout medicine Uloric febuxostat
The U.S. uloric stroke and Drug Administration (FDA) just concluded that there is an added risk of mortality from Uloric (febuxostat) compared to a different gout medicine, allopurinol. The determination is from an in-depth analysis of results from a safety clinical trial which discovered an elevated risk of heart-related death and mortality from all causes when using 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 accepted use of Uloric to specific patients who aren’t treated well-enough or have significant reactions to with allopurinol.
Uloric was originally FDA-approved in 2009 to treat a variety of arthritis called gout in adults. Gout occurs when a naturally occurring substance in the body known as uric acid builds up and creates sudden issues of redness, and discomfort in one or several 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 amount of medicines to treat gout is limited and there is an unmet demand for medications 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 have the following symptoms while taking Uloric:
Shortness of breath
Rapid or irregular heartbeat
Numbness or weakness on one side of your body
Sudden extreme headache
Don’t stop taking Uloric without first talking to your health care professional, as doing so may worsen your gout.
Health care professionals should keep 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 required the drug maker, Takeda Pharmaceuticals, to perform a large postmarket safety clinical trial. The trial was conducted in over 6,000 patients with gout treated with either Uloric or allopurinol. The main outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring intervention, called unstable angina.
Does Your Case Qualify for an Action Against the Makers of Uloric? According to new Black Box warnings required by the FDA, use of Uloric may increase the chances of suffering one of the following side-effects:
Pulmonary Embolism (PE)
Deep Vein Thrombosis (DVT)
If you or a loved one has suffered 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 any expenses, emotional distress, and inconveniences you have endured as a result of your medical treatment.
The attorneys at The Meneo Law Group not only have the ability, experience, and knowledge to represent your Uloric lawsuit, but a proven history of success in representing people, like you, that have been injured by dangerous drugs and products.