Uloric Side Effects

Uloric (febuxostat) is an FDA-approved medication designed to treat gout by lowering uric acid levels in the bloodstream. Though the FDA approved Uloric back in 2009, it wasn’t until February 2019 that they required a black box warning indicating the elevated risk of heart-related deaths.

For this reason, some patients believe Takeda Pharmaceuticals released a defective drug on the market and failed to warn consumers of known risks associated with their product. In addition to heart-related risks, there are other serious Uloric side effects forming the basis of febuxostat lawsuits.

Uloric Side Effects Include Allergic Reactions

Up to 10 percent of people taking Uloric experience a dermatologic side effect. Some 278 of the 2,688 adverse events in the FDA Adverse Events Reporting System were related to allergic reactions.

For some, there is a temporary rash of hives. More serious skin hypersensitivities include Stevens-Johnson Syndrome and toxic epidermal necrolysis. Some patients may experience throat swelling and find it suddenly hard to breathe.

Allergic reactions can be fatal.

Febuxostat Side Effects May Include Heart Attack or Stroke

At least 14 Uloric patients reported congestive heart failure and another six experienced sudden cardiac failure. In the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) trial, gout patients with established cardiovascular disease experienced a significant increase in sudden cardiac deaths compared to those taking Allopurinol – 83 vs. 56.

Indications of a potential heart attack include:

  • Extreme chest discomfort – pressure, squeezing, fullness, or pain – that lasts more than a few minutes.
  • Shortness of breath, often accompanied by sudden, unusual fatigue, particularly in women.
  • Rapid or irregular heartbeat, above 76 beats per minute while at rest.
  • Numbness or weakness down the arm or on one side of the body.

Symptoms of a potential stroke include:

  • Face drooping on one side of the face when smiling.
  • Arm dropping down on one side when both arms are raised.
  • Speech impaired with slurring or strange anomalies when a short phrase is attempted.
  • Dizziness and difficulty walking with balance and coordination.
  • Sudden severe headache.

Liver Problems Are A Possible Side Effect of Gout Medication

In the FDA Adverse Events database, at least nine patients reported jaundice, seven had abnormal increases in liver function, and six suffered renal disorders.

Up to 10 percent of patients taking Uloric experience liver function abnormalities, with ALT and AST readings greater than three times the normal upper limit. Abnormal alkaline phosphatase readings, cholelithiasis, and bilirubin increases are less common, affecting up to 1 percent of users.

In rare cases, blood alkaline phosphatase increases, hepatitis, jaundice, and liver injury occur. Post-marketing reports found that liver function abnormalities occurred more frequently when given with colchicine for gout flare prophylaxis, and with low doses of 40 mg than with higher 80 mg doses.

Signs of liver problems include:

  • Unusual fatigue
  • Loss of appetite for days
  • Darkened “tea-colored” urine
  • Yellowing of the skin or eyes (jaundice)
  • Stomach pain, aching, or tenderness on the upper right side of the stomach area

Blood tests to check liver function are generally recommended before, during, and after gout treatment.

Are You Eligible to File a Uloric Lawsuit?

Chaffin Luhana offers free consultations for all people with questions about filing a Uloric lawsuit.

If we agree to represent your case, we do so at no upfront cost to you. Our clients only pay after we win a settlement or jury award.

The strongest cases involve patients with serious, long-lasting side effects that have greatly disturbed their quality of life and led to losses such as medical bills and lost wages from time off work. If you or a loved one have used febuxostat within the past few years and experienced serious heart-related side effects, contact Chaffin Luhana to learn more about your legal options.