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U.S. Food and Drug Administration (FDA) placed a Boxed Warning for added risk of death with gout prescription drug Uloric (febuxostat)
The U.S. Food and Drug Administration (FDA) just determined there is an increased risk of death with Uloric (febuxostat) relative to another gout medication, 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 death 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 most prominent warning, and a new consumer Medication Guide. The FDA is also minimizing the accepted use of Uloric to certain patients who are not treated well-enough or have severe side effects with allopurinol.

Uloric was originally FDA-approved in 2009 to treat a variety of arthritis called 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 discomfort in one or several joints. Uloric works by reducing uric acid amounts in the blood. Gout is a chronic disease that affects nearly 8.3 million people in America The number of medications to treat gout is small and there is an unmet demand for medications for this disease.

Patients should contact their prescribing physician if they have a history of heart issues or stroke and discuss the advantages and risks of using Uloric to treat their gout. Find emergency medical attention immediately if you get 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

Trouble talking

Sudden severe headache

Do not stop taking Uloric before first speaking with your health care professional, as doing so might worsen your gout.

Health care professionals should limit Uloric for use only for patients who have failed or don’t tolerate allopurinol. Counsel patients regarding 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 potential cardiovascular events in patients treated with Uloric in the current prescribing data and required the drug manufacturer, Takeda Pharmaceuticals, to perform a large postmarket safety clinical trial. The trial was conducted in more than 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 an issue of insufficient blood supply to the heart requiring intervention, called unstable angina.

Does uloric lawsuit Qualify for an Action Against the Makers of Uloric? According to the new Black Box warnings required by the FDA, use of Uloric could 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 treatment of gout, you might be entitled to a settlement from Takeda Pharmaceuticals, as well as for expenses, emotional harm, 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 handle your Uloric lawsuit, but a proven history of success in representing people, like you, that have been harmed by dangerous medications and products.