Our law firm has been investigating Uloric lawsuits for a number of years and is excited to see the FDA finally take action and add a “black box warning” to the drug’s label.
“With over 8 million Americans suffering from painful, intense flareups of Gout, the potential for a Uloric induced cardiovascular health crisis is possible.”
Since entering the U.S. market in February 2009, Uloric (generic name: febuxostat) has been linked to a variety of serious, life-threatening side effects including kidney damage, liver failure, heart attacks, strokes, cardiac risk, severe bleeding events, and bone marrow failure.
Takeda Pharmaceuticals, the company that makes Uloric, is facing a growing number of lawsuits filed in courthouses around the country on behalf of patients who suffered these and other injuries after taking Uloric.
FDA Black Box Warning
On February 21, 2019, the U.S. Food & Drug Administration (FDA) released a Drug Safety Communication, which added a Boxed Warning (often referred to as a ‘Black Box Warning’) to the medication Uloric (febuxostat).
A Black Box Warning is the most serious and severe warning that the FDA requires drug manufacturers to include on products known to cause life-threatening side effects.
This boxed warning was issued after an in-depth review of results from a safety trial that found Uloric had an increased risk of heart attacks, strokes, and heart-related death.
FDA has concluded there is an increased risk of death with Uloric (febuxostat).
Additional Resources & Further Reading:
- Highlights of Prescribing Information – Uloric Label (2019)
- FDA adds Boxed Warning for increased risk of death with Gout medicine Uloric (febuxostat) – FDA Drug Safety Communication
What is Uloric?
Manufactured and marketed by Takeda Pharmaceuticals, Uloric (febuxostat) is a prescription Gout drug that treats joint inflammation by reducing uric acid levels. When it received clearance from the FDA in February 2009, it was the first new Gout medication to hit the U.S. market in more than four decades. Uloric is designed to work by blocking xanthine oxidase, an enzyme needed to create uric acid. The medication comes in once-daily doses of 40-mg and 80-mg.
Uloric Side Effects
Unfortunately, in its short time on the market, Uloric has been linked to a number of serious side effects including:
- Heart attack
- Thrombotic stroke
- Cardiovascular death
- Heart disease
- Liver failure
- Kidney damage
- Renal failure
- Immune system disorders
- Allergic reaction (anaphylaxis, rash, Stevens-Johnson syndrome)
- Psychiatric disorders (psychotic behavior, aggressive thoughts)
- Kidney and urinary disorders
- Bone marrow failure
- Severe bleeding episodes
- And more
FDA Safety Warnings on Uloric Are Not New
After receiving a number of reports of the above-listed health complications in patients treated with Uloric, the FDA has issued several safety warnings and updated the Uloric Medication Guide at least three times; (i) once in January 2011, (ii) then again in November 2012, and (iii) now most recently in February 2019.
Results of 2017 – The FDA has also been investigating the potential of heart attacks, strokes and other heart-related side effects since 2017, when they issued a drug safety communication titled, “FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric).”
In this alert, the FDA stated that they had reviewed a study of approximately 6,000 Gout patients. The results showed that there was an increased risk of the combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery.
Results of 2019 – The FDA has stated that Uloric showed an increased risk of heart-related deaths and death from all causes. In patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year compared to 11 deaths from heart-related causes per 1,000 patients treated with allopurinol for a year. In addition, there were 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol.
Uloric Recall & Other Information
Our lawyers wanted to provide some quick answers to commonly asked questions …
- Has Uloric been recalled? No. There has been no Uloric recall and the medication is still available by prescription from your doctor.
- How much does it cost to hire a Uloric lawyer? Our lawyers offer a 100% free review of your potential case. If we decide to pursue your claim, you will owe nothing unless we obtain a trial verdict or Uloric settlement on your behalf. To find out if you have a case, please call us by dialing (866) 588-0600.
Uloric and Rhabdomyolysis
Rhabdomyolysis, one of the most serious side effects to be linked to Uloric, is a potentially fatal condition that occurs when muscle fibers break down in the body and release myoglobin into the blood. Myoglobin is a protein that can clog the kidneys and affect their ability to function normally. The symptoms of rhabdomyolysis may be difficult to identify because the disease manifests differently from patient to patient. When they do present, however, symptoms of rhabdomyolysis typically include varying degrees of:
- abnormal urine color (dark, red, cola-colored)
- decreased urine production
- general weakness
- muscle stiffness or aching (myalgia)
- muscle tenderness
- weakness of the affected muscles
Uloric Liver Failure
During pre-approval clinical trials, elevated liver enzyme levels were found to occur in 4-6% of patients treated with Uloric. In most cases, these levels returned to normal after the patients discontinued their regimen of the drug. Approximately 2% of Uloric users reported elevated liver enzymes three times the upper-limit of normal, a level so high it can quickly lead to full-blown liver failure. Symptoms of Uloric liver failure may include:
- Abdominal pain and discomfort
- Confusion, disorientation
- Changes in personality or behavior
Uloric Renal Failure
Kidney problems are common among patients with gout, according to the Mayo Clinic. The conditions are related since a waste product called uric acid naturally found in the bloodstream is filtered through the kidneys.
Renal failure is a serious, potentially fatal medical condition in which a person’s kidneys function at less than 15% of their normal capacity. The term “renal failure” describes a broad range of kidney problems which are categorized according to symptoms and other factors, including acute renal failure (rapid onset of symptoms) and chronic renal failure (long-term, slow onset of symptoms). Renal failure is also known as kidney failure, end-stage renal disease, or simply ‘ESRD’.
Study Finds Increased Kidney Disease Risk with Uloric
A 2019 post-marketing study published in the journal Arthritis Research and Therapy looked at cases of acute renal failure (ARF) associated with febuxostat (the active ingredient in Uloric) and allopurinol (Zyloprim). The study, titled “Acute kidney injury associated with febuxostat and allopurinol,” found that acute renal failure was reported 5.7 and 3.3 times more frequently with febuxostat and allopurinol than for other similar medications. The researchers advised physicians to exercise caution when prescribing the drugs to patients with pre-existing kidney problems and other risk factors.
Acute Kidney Failure Symptoms
- Decreased urine output
- Fluid retention, causing swelling in your legs, ankles or feet
- Shortness of breath
- Irregular heartbeat
- Chest pain or pressure
Source: Mayo Clinic
Chronic Kidney Failure Symptoms
- Loss of appetite
- Fatigue and weakness
- Sleep problems
- Changes in how much you urinate
- Decreased mental sharpness
- Muscle twitches and cramps
- Swelling of feet and ankles
- Persistent itching
- Chest pain
- Shortness of breath
- High blood pressure (hypertension)
Source: Mayo Clinic
Whistleblower Lawsuit Alleges Takeda Hid Safety Data Regarding Uloric Side Effects
A whistleblower lawsuit filed on behalf of former Takeda employee Dr. Helen Ge who accused the company of withholding critical safety information about Uloric’s potentially serious side effects.
The complaint alleged that Takeda defrauded Medicare and Medicaid by failing to report that Uloric can cause severe health consequences.
Ge also claimed that complications from Uloric led to the deaths of several patients taking the drug.
“Takeda … intentionally misrepresented and altered the descriptions of adverse events in reports, and intentionally misclassified adverse events as ‘non-serious’ or as ‘labeled’ drug-drug interactions, to avoid filing 15-day adverse event reports.”
Additionally, the claims made by Dr. Ge showed that the company did not reveal available risk information about Uloric and its possible serious side effects regarding liver problems, kidney damage, and bone marrow failure. But also that the manufacturer made the cardiac side effects (heart attacks) of Uloric less severe than in reality by modifying and altering documents sent to the FDA.
Do I Have a Uloric Lawsuit?
The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Uloric lawsuits. We are handling individual litigation nationwide and currently accepting new Uloric side effect and adverse event cases in all 50 states.
Free Case Evaluation: Again, if you or a loved one has been the victim of a Uloric induced side effect including heart attack, stroke or other cardiovascular emergency, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.