US Food and Drug Administration FDA has issued Boxed Warning for increased risk of death from gout medication Uloric febuxostat
The U.S. Food and Drug Administration (FDA) just concluded there is an added risk of death from Uloric (febuxostat) compared to another gout medicine, allopurinol. The conclusion is from an in-depth review of results from a safety clinical trial that determined an increased risk of heart-related death and death from all causes with 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 consumer Medication Guide. The FDA is also minimizing the approved use of Uloric to specific patients that are not treated effectively or have severe side effects with allopurinol.
Uloric was FDA-approved in 2009 as a treatment for a variety of arthritis known as gout in adults. Gout happens when a naturally occurring substance in the body known as uric acid builds up and causes sudden attacks of redness, and discomfort in one or more joints. Uloric works by lowering uric acid amounts in the blood. Gout is a chronic disease that affects approximately 8.3 million adults in America The number of medicines to treat gout is low and there is an unmet need for medications for this disease.
Users should tell 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 immediately if you have the following symptoms while taking Uloric:
Chest pain
Shortness of breath
Rapid or irregular pulse
Numbness or weakness on one side of your body
Light-headedness
Difficulty speaking
Sudden severe headache
Do not stop taking Uloric without first talking to your health care professional, as doing so could worsen your gout.
Health care professionals should reserve Uloric for use only for patients that have failed or do not tolerate allopurinol. Counsel patients about 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 included a Warning and Precaution regarding possible cardiovascular events in patients treated with Uloric in the current prescribing information and mandated 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. uloric stroke 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 Issue Qualify for a Lawsuit Against the Makers of Uloric? According to new Black Box warnings mandated by the FDA, use of Uloric may increase the chances of suffering one of the following side-effects:
Death
Heart Attack
Stroke
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 distress, and inconveniences you have experienced as a result of your medical treatment.
The attorneys at The Meneo Law Group not only have the ability, experience, and expertise to represent your Uloric lawsuit, but a proven history of success in representing people, like you, who have been injured by dangerous drugs and products.
