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ULORIC

Gout drug linked to deadly consequences

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WARNING: ULORIC LINKED TO INCREASED RISK OF HEART-RELATED DEATH

Patients’ dependency on Uloric may lead to deadly consequences! Recent clinical trials reveal the popular gout drug Uloric increases users' risk of heart-related death and death.  

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ULORIC BACKGROUND

Uloric, also known as febuxostat, is a prescriptive drug used to treat gout, a type of uncomfortable and painful arthritis found in adults. Gout occurs when too much uric acid builds up in the body and the body cannot adequately dispose of it. The build up of uric acid then causes inflammation, swelling, and the destruction of cartilage and bone. Patients with gout typically experience a build up of xanthine oxidase, an enzyme that gets converted to uric acid. Doctors prescribe Uloric because it inhibits xanthine oxidase (XO) and lowers XO numbers in the body, therefore helping with the chronic management of hyperuricemia in patients with gout. 

Manufactured by Takeda Pharmaceuticals, the FDA approved Uloric in February 2009 to lower uric acid levels in a patient’s blood and quickly became a popular medication among consumers to relieve their discomfort. Over 1 million prescriptions for Uloric get prescribed annually, making Uloric one of Takeda Pharmaceuticals more lucrative drugs. In fact, Uloric costs more than other gout drugs on the market, costing $353 per prescription. However, the FDA rejected Uloric's New Drug Application (NDA) application twice before the tentative 2009 approval. The FDA expressed initial concerns with the product's ability to cause Major Adverse Cardiac Events (MACE). So when Uloric was approved, the FDA made Uloric go through a Phase 4 Study, a post-marketing study to provide additional information about Uloric's risks, benefits, and best uses. To consumers' dismay, the trials revealed the deadly consequences of Uloric.

WHAT'S WRONG WITH ULORIC?

As of February 21, 2019, the FDA issued a safety announcement that there's an increased risk of heart-related death and death when taking Uloric compared to allopurinol, another gout medicine for adults. After a substantial assessment of results from a safety clinical trial, the FDA’s health officials concluded that when comparing the Uloric test group to the allopurinol test group, “cardiovascular death and deaths from any cause were more frequent in the Uloric group than in the Allopurinol group”.
Following this discovery, the FDA added a new Medication Guide and a Boxed Warning for Uloric. This Black Box Warning, the most serious warning mandated by the FDA, includes a prominently placed label with crucial information. The label informs users and members of the medical community about the new increased risk of cardiovascular difficulties and related death from taking Uloric and combining medications while taking Uloric.

The new Medication Guide now shows the recent, limited approved use of Uloric. The FDA recommends that Uloric only be prescribed to specific patients who experience difficulties, ineffectiveness, or intense side effects when taking allopurinol. 

The inception of concerns about Uloric began in 2012 when a previous Takeda Pharmaceuticals safety consultant, Helen Ge, filed a whistleblower lawsuit. Ge alleged in her lawsuit that by not reporting the dangerous side effects of Uloric when using it in combination with additional drugs, Takeda Pharmaceuticals defrauded both Medicaid and Medicare. 
If Ge's claim is proven to be true, Takeda Pharmaceuticals could find themselves in severe hot water for knowingly selling a dangerous pharmaceutical drug without adequately informing consumers about its dangerous and potentially lethal side effects.

CRUCIAL NEXT STEPS

Patients currently taking Uloric are encouraged to inform your current health care professional if you have a history of heart problems or stroke. 

According to the FDA, patients must seek emergency medical attention immediately if you experience[d] the listed side effects while taking Uloric.
Chest pain
Shortness of breath
Rapid or irregular heartbeat
Numbness or weakness on one side of your body
Dizziness
Trouble talking
Sudden severe headache
If you, a family member, or a friend has experienced heart related complications or death from taking Uloric, contact AVA Law Group, Inc. today. We are here for you, and we want to make sure that the pain you and your loved ones have experienced is not in vain. We want to fight for your right to compensation and be a empathetic guide for you through this trying time.

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ATTORNEY ADVERTISEMENT: Not available in all states, Andrew Van Arsdale, supervising attorney is licensed only in CA, but associates with attorneys throughout the country, Principal office: 3667 Voltaire Street, San Diego, CA 92106. 


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