- Member Since: August 21, 2019
U.S. Food and Drug Administration (FDA) adds a Boxed Warning for increased risk of death with gout medication Uloric (febuxostat)
The U.S. Food and Drug Administration (FDA) has determined that there is an added risk of mortality from Uloric (febuxostat) relative to a competing gout medication, allopurinol. The conclusion is based on our in-depth review of results from a safety clinical trial which determined an increased 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 limiting the accepted use of Uloric to specific patients that aren’t treated well-enough or have severe reactions to with allopurinol.
Uloric was 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 aggregates and creates sudden issues of redness, and discomfort in one or more joints. Uloric works by lowering uric acid levels in the blood. Gout is a chronic disease that affects approximately 8.3 million adults in the U.S. The amount of medicines to treat gout is limited and there is a high demand for treatments for this disease.
Patients should tell their health care professional if they have a history of heart problems or stroke and explore the benefits and risks of using Uloric to treat their gout. Find emergency medical attention immediately if you have the following symptoms while taking Uloric:
Shortness of breath
Rapid or irregular pulse
Numbness or weakness on one side of your body
Sudden extreme headache
Don’t stop taking Uloric before first speaking with your health care professional, as doing so could worsen your gout.
Health care professionals should reserve 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 the moment 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 mandated the drug maker, Takeda Pharmaceuticals, to perform a large postmarket safety clinical trial. The trial was performed in more than 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 uloric heart attack Qualify for an Action Against the Makers of Uloric? According to new Black Box warnings mandated by the FDA, use of Uloric could increase the risk of suffering one of the following side-effects:
Pulmonary Embolism (PE)
Deep Vein Thrombosis (DVT)
If you or a loved one has experienced any of the above while using 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 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 handle your Uloric lawsuit, but a proven track record of success in representing people, like you, that have been harmed by dangerous drugs and products.