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Meyer Justice posted an update 5 years, 6 months ago
The U.S. Food and Drug Administration (FDA) just determined there is an enhanced risk of mortality with Uloric (febuxostat) compared to another gout medicine, allopurinol. This determination is based on our in-depth study of results from a safety clinical trial that found an increased risk of heart-related death and mortality 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 most prominent warning, and a new user Medication Guide. The FDA is also limiting the accepted use of Uloric to specific patients who are not treated effectively or experience severe side effects with allopurinol.
Uloric was originally FDA-approved in 2009 as a treatment for a type of arthritis known as gout in adults. Gout happens when a naturally occurring substance in the body known as uric acid aggregates and causes 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 people in the U.S. The number of medications to treat gout is low and there is a high need for medications for this disease.
Consumers should tell their health care professional if they have a history of heart issues or stroke and explore the benefits and risks of using Uloric to treat their gout. Find emergency medical attention immediately 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
Dizziness
Trouble speaking
Sudden severe headache
Do not 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 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 issues 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.
uloric lawsuit 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 inadequate blood supply to the heart requiring intervention, called unstable angina.
Does Your Issue Qualify for an Action Against the Manufacturers of Uloric? According to new Black Box warnings required by the FDA, use of Uloric may increase the risk of experiencing one of the following side-effects:
Death
Heart Attack
Stroke
Pulmonary Embolism (PE)
Deep Vein Thrombosis (DVT)
If you or a loved one has suffered any of the above while using Uloric for the condition of gout, you might be entitled to a settlement from Takeda Pharmaceuticals, as well as for expenses, emotional distress, and inconveniences that 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 manage your Uloric lawsuit, but a proven track record of success in representing people, like you, who have been injured by dangerous drugs and products.
