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U.S. Food and Drug Administration (FDA) placed a Boxed Warning due to added risk of mortality with gout prescription drug Uloric (febuxostat)

por Marietta Kaczmarek (2019-08-23)


loading-dudes-transparent.gifThe U.S. Food and Drug Administration (FDA) has determined there is an added risk of harm with Uloric (febuxostat) relative to a competing gout medicine, allopurinol. The determination is based on our in-depth study of results from a safety clinical trial that discovered an elevated 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 user Medication Guide. The FDA is also minimizing the approved use of Uloric to specific patients that aren’t treated effectively or experience significant side effects from allopurinol.

Uloric was FDA-approved in 2009 to treat a variety of arthritis called gout in adults. Gout occurs when a naturally occurring substance in the body known as uric acid aggregates and causes sudden attacks of swelling, and pain in one or several joints. Uloric works by lowering uric acid levels in the blood. Gout is a chronic affliction that affects approximately 8.3 million people in the U.S. The number of medicines to treat gout is low and there is a high need for medications for this disease.

Consumers should contact their prescribing physician if they have a history of heart problems or stroke and explore the advantages and risks of using uloric stroke to treat their gout. Find emergency medical attention right away 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
Light-headedness
Difficulty talking
Sudden severe headache
Do not stop taking Uloric before first speaking with your health care professional, as doing so may worsen your gout.

Health care professionals should limit Uloric for use only for patients that 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 possible cardiovascular events 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. The trial was conducted 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 a condition 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 the new Black Box warnings required by the FDA, use of Uloric could increase the chances 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 suffered 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 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 skill, experience, and expertise to manage your Uloric lawsuit, but a proven track record of success in representing people, like you, that have been harmed by dangerous drugs and products.