Uloric® (Febuxostat) is a medication used to treat gout, which is a debilitating type of arthritis that occurs when uric acid builds up in the blood and causes inflammation in the joints. Uloric treats gout by inhibiting the enzyme xanthine oxidase, which reduces the amount of uric acid in the body. Uloric is manufactured by Takeda Pharmaceuticals, a Japanese-based pharmaceutical company. When it was approved by the FDA in 2009, it was the first new gout drug in over 40 years.
FDA WARNINGS & PRECAUTIONS FOR ULORIC
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). Additional FDA warnings and precautions related to Uloric use include:
- LIVER FAILURE
- KIDNEY DAMAGE
- HEART ATTACK
- IMMUNE SYSTEM DISORDERS
- ALLERGIC REACTION (ANAPHYLAXIS, RASH, STEVENS JOHNSON SYNDROME)
- PSYCHIATRIC DISORDERS (PSYCHOTIC BEHAVIOR, AGGRESSIVE THOUGHTS)
- KIDNEY & URINARY DISORDERS
- BONE MARROW FAILURE
- SEVERE BLEEDING
ULORIC + RISK OF HEART-RELATED DEATH
FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. FDA required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when the medicine was approved in 2009. Once the final results from the manufacturer are received, FDA will conduct a comprehensive review and will update the public with any new information. The febuxostat drug labels already carry a Warning and Precaution about cardiovascular events because the clinical trials conducted before approval showed a higher rate of heart-related problems in patients treated with febuxostat compared to allopurinol. These problems included heart attacks, strokes, and heart-related deaths. As a result, FDA required an additional safety clinical trial after the drug was approved and on the market to better understand these differences, and that trial was finished recently.
The safety trial was conducted in over 6,000 patients with gout treated with either febuxostat or allopurinol. The primary outcome was a 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. The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.
ULORIC + 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
DO YOU HAVE QUESTIONS ABOUT INJURIES RELATED TO ULORIC?
If you or a loved one have been affected by the drug Uloric, we encourage you to consult with our team as soon as possible. With our extensive knowledge and expertise, you can rest assured that should you choose to work with us, you will have legal representation that you can trust. All initial consultations are free, and we don’t charge any up-front fees for representation. We handle all fees on a contingency basis, meaning that unless we’re successful, you don’t have to pay us. Please contact us at (405)510.0077 for a free consultation or request a case review here.