US Food and Drug Administration FDA placed a Boxed Warning for increased risk of mortality from gout medicine Uloric febuxostat
The U.S. Food and Drug Administration (FDA) has determined that there is an added risk of harm from Uloric (febuxostat) when compared to a different gout medication, allopurinol. The determination is based on our in-depth review of results from a safety clinical trial which determined an elevated 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 consumer Medication Guide. The FDA is also minimizing the approved consumption of Uloric to certain patients that are not treated well-enough or have significant reactions to with allopurinol.
Uloric was FDA-approved in 2009 as a treatment for a variety of arthritis referred to as gout in adults. Gout happens when a naturally occurring substance in the body known as uric acid scales up and causes sudden issues of redness, and pain in one or several joints. Uloric works by reducing uric acid levels in the blood. Gout is a chronic disease that affects nearly 8.3 million people in the U.S. The number of medicines to treat gout is low and there is an unmet need for treatments for this disease.
Consumers should tell their health care professional if they have a history of heart issues or stroke and discuss the benefits and risks of using Uloric to treat their gout. Seek 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 extreme headache
Do not stop taking Uloric without first speaking with your health care professional, as doing so might worsen your gout.
Health care professionals should keep Uloric for use only in patients who have failed or do not tolerate allopurinol. Counsel patients about the cardiovascular risk with Uloric and advise them to seek medical attention immediately if they experience the symptoms listed above.
When the FDA approved Uloric in 2009, they added a Warning and Precaution regarding possible 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 over 6,000 patients with gout treated with either Uloric or allopurinol. uloric lawsuit 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 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 experiencing one of the following conditions:
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 condition of gout, you might be entitled to a settlement from Takeda Pharmaceuticals, as well as for any expenses, emotional harm, 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.
