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U.S. Food and Drug Administration (FDA) has issued Boxed Warning due to increased risk of death with gout medicine Uloric (febuxostat)

por Sol Seward (2019-08-22)


The U.S. Food and Drug Administration (FDA) has concluded that there is an enhanced risk of death from Uloric (febuxostat) when compared to a competing gout medication, allopurinol. This determination is based on our in-depth study of results from a safety clinical trial which found an elevated risk of heart-related death and mortality from all causes when using Uloric.

foodGoing forward, 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 limiting the approved consumption of Uloric to specific patients who are not treated well-enough or have significant side effects with allopurinol.

uloric stroke was FDA-approved in 2009 as a treatment for a variety of arthritis called gout in adults. Gout happens when a naturally occurring substance in the body known as uric acid builds up and causes sudden attacks of swelling, and discomfort in one or more joints. Uloric works by lowering 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 medications to treat gout is limited and there is a high need for treatments for this disease.

Users should tell their health care professional if they have a record 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:

Chest pain
Shortness of breath
Rapid or irregular pulse
Numbness or weakness on one side of your body
Dizziness
Trouble talking
Sudden extreme 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. Counsel patients regarding 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 included a Warning and Precaution regarding potential cardiovascular issues 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 performed in over 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 Case Qualify for a Lawsuit Against the Manufacturers of Uloric? According to new Black Box warnings mandated by the FDA, use of Uloric can elevate the risk 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 suffered any of the above while taking Uloric for the condition of gout, you may be entitled to a settlement from Takeda Pharmaceuticals, as well as for expenses, emotional harm, and inconveniences that you have experienced 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, that have been harmed by dangerous medications and products.