ULORIC HEART INJURIES
Patients’ dependency on Uloric may lead to deadly consequences. Recent clinical trials reveal the popular gout drug increases users' risk of heart-related death and death.
If you, a family member, or a friend has experienced heart related complications or death from taking Uloric, contact AVA Law Group today. We are here for you and fight for your right to compensation during this trying time.
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 assessing 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, informs users and members of the medical community about the new increased risk of cardiovascular difficulties and related death from taking and/or combining medications while taking Uloric. However, the new label came too late for patients currently taking the toxic gout medication.
The FDA now recommends that Uloric only be prescribed to specific patients who experience difficulties, ineffectiveness, or intense side effects when taking allopurinol.
TOXIC SIDE EFFECTS
Patients currently taking Uloric are encouraged to inform your current health care professional if you have a history of heart problems or stroke. Contact your healthcare provider immediately if you experience the following side effects after taking Uloric:
- Chest pain
- Shortness of breath
- Rapid or irregular heartbeat
- Numbness or weakness on one side of the body
- Trouble talking
- Sudden severe headache
WHAT WENT WRONG?
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. Following its release, the gout drug quickly became a popular medication among consumers to relieve their discomfort. Over 1 million prescriptions for Uloric get prescribed annually. This makes 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). When Uloric was approved, the FDA made the drug go through a post-marketing study to provide additional information about possible risks, benefits, and best uses for the drug. The trials revealed potentially deadly consequences of taking the popular gout medication.
In 2012, previous Takeda Pharmaceuticals safety consultant, Helen Ge, filed a whistleblower lawsuit against Takeda Pharmaceuticals. Ge alleged 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.
Takeda Pharmaceuticals could find themselves liable for knowingly selling a dangerous pharmaceutical drug without adequately informing consumers about its dangerous and potentially lethal side effects.
ULORIC LEGAL REPRESENTATION
If you or a family member 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. Contact AVA Law Group now for your free, no-obligation case evaluation!