Uloric (febuxostat) is a drug that prevents flare-ups of gout, a painful medical condition that causes severe arthritis. Although Uloric has only been on the market since 2009, lawsuits have already been filed against its manufacturer, Takeda Pharmaceuticals, for failing to warn about severe, life-threatening side effects.

Update: FDA Requires New ‘Black Box Warning’ on Uloric

On February 21, 2019, the FDA issued a Drug Safety Communication which included a Boxed Warning — often referred to as a ‘black box warning’ — to the labeling of Uloric. The warning was issued after a comprehensive review of a recent safety trial that found Uloric had an increased risk of heart attacks, strokes, and heart-related death.

What is Uloric?

Uloric (febuxostat) is a once-daily oral medication that treats gout, a chronic and painful medical condition that is caused by high levels of uric acid. It is manufactured by Takeda Pharmaceuticals and was approved for sale in the United States in 2009.

Uloric Lawsuits

Pharmaceutical companies must disclose known side effects of their medications to patients, doctors, and the FDA. In 2010, a whistleblower lawsuit was filed by Dr. Helen Ge, a Harvard clinical researcher employed as a safety reviewer for Takeda from 2008 until she was fired 2010. Soon afterward, she filed a lawsuit alleging that Takeda executives were under-reporting adverse events associated with Uloric, Actos, Prevacid, and Kalidex/Dexilant.

Adverse events associated with Uloric included drug interactions, bleeding, bone marrow failure, kidney problems, and more. Currently, Takeda is facing over 1,500 lawsuits from people who allege that Takeda hid risk information linking the diabetes drug Actos (pioglitazone) and bladder cancer.

According to Dr. Helen Ge’s lawsuit, filed in the U.S. District Court for Massachusetts:

“Had Takeda properly reported Uloric’s adverse reactions, the unsafe drug interactions for the gout patient population would have undermined Uloric’s claimed advantages over allopurinol, which ostensibly justified the added expense. Acutely aware of its precarious marketing posture relative to a cheaper, safer, established gout treatment, Takeda resorted to deceitful reporting.”

Uloric and Gout

Gout occurs when there is more than 6 mg/dL of uric acid in the bloodstream, which causes needle-like crystals of monosodium urate to accumulate in body tissues (especially the joints), causing extremely painful inflammation, swelling, arthritis, chalkstones, and progressive destruction of the joint.

Uloric treats gout by inhibiting xanthine oxidase (XO), an enzyme that is necessary for the body to convert xanthine into uric acid. This reduces the amount of uric acid in the body, which prevents painful and debilitating flare-ups of gout. This mechanism of treating gout is very similar to Zyloprim (allopurinol).

FDA Safety Warning for Uloric and Liver Damage

In November 2012, the U.S. Food and Drug Administration (FDA) published a Safety Warning to warn about cases of fatal and non-fatal liver failure in patients on Uloric. During clinical trials, 6.6% of Uloric patients developed abnormal liver function, and 2% developed liver enzyme levels greater than 3X the upper-limit of normal, which is a symptom of liver damage. The FDA recommends liver tests in patients who have symptoms of liver damage, including abdominal pain, loss of appetite, fatigue, dark urine, and jaundice (yellowing of skin, eyes).

Uloric Side Effects

  • Nausea
  • Liver failure
  • Kidney disease
  • Kidney failure
  • Renal failure
  • Rhabdomyolysis
  • Heart attack
  • Stroke
  • Rash
  • 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
  • And more

Uloric Renal Failure

Kidney problems are common among patients with gout. Most often, kidney disease causes gout, but having gout can also lead to kidney disease over time. The conditions are related since uric acid, a waste product naturally found in the bloodstream, is filtered through the kidneys. People with kidney disease are unable to process uric acid, and having too much uric acid in your blood can cause gout.

Study Finds Increased Kidney Injury Risk with Uloric

A 2019 post-marketing study titled “Acute kidney injury associated with
febuxostat and allopurinol”
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 researchers conducted a case/non-case study of patients enrolled in the World Health Organization’s VigiBase® pharmacovigilance database between January 1, 2008, and December 31, 2018.

Among 3509 “suspected drug” notifications for febuxostat and 18,730 for allopurinol, the researchers identified 317 and 1008 cases of ARF, respectively. Acute renal failure was reported 5.7 and 3.3 times more frequently for febuxostat and allopurinol than for other similar medications. As a result of these findings, the study’s authors recommended that physicians exercise caution when prescribing the drugs to patients with pre-existing kidney problems and other risk factors.

What is Renal Failure?

Renal failure is a life-threatening condition in which a person’s kidneys function at less than 15% of normal. The disease includes many different kidney problems which are further classified depending on symptoms:

  • Acute kidney failure – Occurs when the kidneys suddenly become unable to filter waste products from the blood. This form of the disease is usually found in hospitalized patients and may resolve over time.
  • Chronic kidney failure – Develops gradually, usually over years or even decades, often with few recognizable symptoms. When chronic kidney failure reaches an advanced stage, dangerous levels of fluid, electrolytes and wastes build up in the body.

In September 2017, the labeling of Uloric was updated with the recommendation that patients with severe renal impairment be limited to a dose of 40mg once daily. The recommendation for patients with mild to moderate renal impairment remained the same (Clcr 30 to 89 mL/min).

Acute Kidney Failure Symptoms

  • Decreased urine output
  • Fluid retention, causing swelling in your legs, ankles or feet
  • Shortness of breath
  • Fatigue
  • Confusion
  • Nausea
  • Weakness
  • Irregular heartbeat
  • Chest pain or pressure
  • Seizures
  • Coma

Source: Mayo Clinic

Chronic Kidney Failure Symptoms

  • Nausea
  • Vomiting
  • 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

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