Our lawyers are currently investigating potential Uloric lawsuits for former users of the drug who suffered serious injuries. Since entering the U.S. market in February 2009, Uloric (febuxostat) has been repeatedly linked to serious side effects including kidney damage, liver failure, heart attacks, strokes, 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.
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 Food and Drug Administration (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:
- Liver failure
- Kidney damage
- Heart attack
- 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
FDA Safety Warning on Uloric
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 twice, once in January 2011 and then again in November 2012.
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 protien 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
Whistleblower Lawsuit Alleges Takeda Hid Safety Data Re. Uloric Side Effects
In 2012, a whistleblower lawsuit filed on behalf of former Takeda employee Helen Ge accused the company of withholding critical safety information about Uloric’s potential serious side effects. The complaint alleged that Takeda defrauded Medicare and Medicaid by failing to report that Uloric can cause severe health consequences when taken together with other prescription medications including digoxin, imuran, methadone, and warfarin. Ge claimed that the resulting complications from these drug interactions led to the deaths of several Uloric users.
“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.”
In November 2012, Ge’s lawsuit was dismissed after a judge ruled that her allegations weren’t specific enough. However, in August 2013, the U.S. government filed an amicus brief in support of Ge, disagreeing with the judgement and urging the court to reconsider its decision.