Medical Drugs

Uloric (febuxostat) Litigation

No longer accepting claims for this case

Takeda Pharmaceuticals’ Uloric®, one of few gout medications on the market, was approved in 2009 to treat joint pain, swelling and other symptoms by lowering uric acid levels in the blood. The U.S. Food and Drug Administration announced a decade later, however, that the drug appears to be linked to severe complications in patients, including an increased risk of heart failure or even death.

Uloric and FDA Black Box Warning

Gout, a form of arthritis, affects roughly 8.3 million people in the U.S., according to the FDA, yet few medications are available to treat the chronic disease. While Uloric was marketed in 2009 as the first new treatment option for patients in more than 40 years, studies have suggested that any benefit of the drug may come at an extreme risk.

The FDA announced in February 2019 that the results of a safety clinical trial found an increased risk of heart-related  death and death from all causes with Uloric compared with another gout medication, allopurinol. The trial, which involved more than 6,000 patients, found 15 deaths from heart-related causes for every 1,000 patients who took Uloric for a year, compared with 11 deaths for those who took allopurinol, according to the FDA. There were also 26 deaths from any cause for every 1,000 patients who took Uloric for the same time period compared with 22 deaths for those who took allopurinol.  

In response to what it found to be an increased risk associated with Uloric, the FDA issued a black box warning for the drug — the agency’s most prominent warning reserved for products that could cause serious injury or death. The FDA also restricted Uloric to treat only certain patients who do not respond or experienced severe side effects while taking allopurinol.

Uloric Side Effects

Patients who take Uloric may experience severe heart-related complications, such as:

  • Heart-related death
  • Stroke
  • Heart attack

Anyone who experiences a heart-related complication while taking Uloric is encouraged to report the side effect to the FDA.

Our Medical Drug Litigation Experience   

Motley Rice medical attorneys have extensive litigation experience involving patients who suffered severe adverse effects and complications caused by dangerous prescription and over-the-counter drugs. We understand that as a patient or family member, your familiarity with medications you have been prescribed, and knowledge of potential risks, may be limited. Our attorneys have the resources needed to thoroughly investigate and identify potentially harmful products, medical causation, compliance with FDA regulations, alleged inadequacy of warnings, alleged wrongdoing and other factors that could affect your potential claim.  

In addition to reviewing potential Uloric cases, our attorneys hold leadership positions and have represented clients in several medical drug cases, including Motley Rice medical attorney Kimberly Barone Baden who currently serves as co-lead counsel for Zofran®, multidistrict litigation and serves a member of the Plaintiffs’ Executive Committee for Viagra. Additional medical drugs under review by our attorneys include diabetes drugs Januvia®, Victoza®, Janumet®, and Byetta®; chemotherapy drug Taxotere®; and MS medication Zinbryta®,  among others.

Consult a medical professional before stopping or changing any medication.