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.
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
- 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
- And more