Gout Drug Uloric Serious Side Effects. Uloric, which is manufactured by Takeda Pharmaceuticals, received U.S. Food and Drug Administration (FDA) approval in February 2009. At that time, Uloric was touted as the first new gout medication in over four decades. Since then, the drug has been routinely tied to significant side effects and is the focus of mounting lawsuits nationwide over alleged Uloric injuries.
Uloric (febuxostat) inhibits xanthine oxidase, an enzyme used by the body to create uric acid, which can develop into gout if a high enough level is reached. Uloric works as a treatment for painful joint-swelling by reducing uric acid levels; it is prescribed in 40 and 80 milligram daily doses.
Uloric Side Effects May Include Rhabdomyolysis, Liver Failure, & Others
After receiving increasing reports of serious health complications in patients treated with Uloric, the agency issued a number of safety warnings and also updated the Uloric Medication Guide in January 2011 and November 2012. Uloric has been associated with an array of serious side effects, including:
- Liver failure
- Allergic reaction: anaphylaxis, rash, Stevens-Johnson syndrome
- Bone marrow failure
- Heart attack
- Immune system disorders
- Kidney damage, kidney and urinary disorders
- Psychiatric disorders: psychotic behavior, aggressive thoughts
- Severe bleeding
Uloric and Rhabdomyolysis
Rhabdomyolysis, one of the most significant adverse reactions associated with Uloric, is a potentially fatal condition that involves muscle fiber breakdown that causes the release of the protein myoglobin into the bloodstream. The kidneys may become clogged when they attempt to filter myoglobin, which affects the organs’ ability to function normally and can lead to kidney damage. The side effect information for Uloric was updated in January 2011 to include rhabdomyolysis as a potential adverse reaction.
Symptoms may be difficult to identify as rhabdomyolysis will manifest differently in patients and may include:
- Abnormal urine color that may be dark, red, brownish
- Decreased urine production
- General weakness, fatigue
- Joint pain
- Muscle issues: stiffness, myalgia (muscle ache), tenderness, aching, weakness
- Uloric Liver Failure
Uloric and Liver Failure
Liver failure is another of the more serious adverse reactions tied to treatment with Uloric.
During clinical trials conducted prior to approval, increased liver enzyme levels were detected in 4-6 percent of patients taking Uloric. Levels typically returned to normal after Uloric was discontinued; however, some 2 percent of Uloric users experienced increased liver enzymes that were three times greater than the upper limit of the normal level. This represents such an increased level that full liver failure may quickly occur. Because of this, patients treated with Uloric are urged to undergo regular blood testing to check liver function.
Symptoms of Uloric liver failure may include:
- Abdominal pain, discomfort (upper, right side)
- Confusion, disorientation
- Jaundice (yellowing of the skin, eyes)
- Personality or behavioral changes
Uloric Whistleblower Lawsuit Alleged Takeda Hid Side Effects Information
In 2012, a whistleblower lawsuit was filed on behalf of a former Takeda safety consultant who accused the drug maker of withholding critical safety information about Uloric’s potential for serious side effects. The lawsuit alleged that Takeda defrauded Medicare and Medicaid by neglecting to report that Uloric can lead to serious health consequences when taken in combination with other prescription medications, including digoxin, imuran, methadone, and warfarin. The whistleblower claimed that Uloric complications associated with these drug interactions were responsible for the deaths of several patients diagnosed with gout who had taken Uloric.
According to whistleblower allegations, Takeda “intentionally misrepresented and altered” adverse event description reports and “misclassified adverse events as ‘non-serious’ or as ‘labeled’ drug-drug interactions”; this was in order “to avoid filing 15-day adverse event reports.”
The lawsuit was dismissed in November 2012 when the judge ruled that the allegations were not sufficiently specific. In August 2013, the U.S. government filed an amicus brief supporting the whistleblower, disagreeing with the prior judgment, and urging the court to reconsider its decision.