The U.S. Food and Drug Administration (FDA) just concluded that there is an added risk of death with Uloric (febuxostat) compared to another gout medication, 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.

Going forward, the FDA has mandated 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 minimizing the accepted consumption of Uloric to specific patients who are not treated effectively or have significant reactions to with allopurinol.

Uloric was originally FDA-approved in 2009 to treat a type of arthritis referred to as gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and creates sudden attacks of redness, and discomfort in one or more joints. Uloric works by lowering uric acid levels in the blood. Gout is a chronic affliction that affects approximately 8.3 million people in America The amount of medications to treat gout is small and there is an unmet need for treatments for this disease.

Users should tell their prescribing physician 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 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

Trouble talking

Sudden extreme headache

Do not stop taking Uloric without first speaking with your health care professional, as doing so could worsen your gout.

Health care professionals should limit Uloric for use only for 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 added a Warning and Precaution regarding possible cardiovascular events in patients treated with Uloric in the current prescribing information and required the drug maker, Takeda Pharmaceuticals, to conduct 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 result was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of insufficient blood supply to the heart requiring intervention, called unstable angina.

Does Your Case Qualify for an Action Against the Makers of Uloric? According to the new Black Box warnings required by the FDA, use of Uloric may 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 condition of gout, you may be entitled to a settlement from Takeda Pharmaceuticals, as well as for any expenses, emotional harm, and inconveniences 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 drugs and products.