FDA Issues Black Box Warning for Uloric

by Dan Reo | Last Updated: August 16, 2019

pill bottleIn February 2019, the FDA issued a “black box warning” – the agency’s strongest and most prominent advisory — for Takeda’s popular gout drug, Uloric. According to health regulators, Uloric (febuxostat) is associated with an “increased risk of heart-related death and death from all causes” compared to the gout medication allopurinol. The boxed warning also cautions that Uloric should be reserved for patients who did not respond to other gout treatment or suffered adverse side effects from allopurinol.

Uloric black box warning

The Uloric black box warning is based on the results of a post-market clinical trial that the FDA required Takeda to conduct.

The safety trial included 6,190 patients who were randomly separated and treated for gout with either febuxostat or allopurinol. The results showed that Uloric exposure was linked to heart-related death, heart attacks, non-fatal strokes, and unstable angina – a condition that requires immediate medical intervention.

According to the study, published in the New England Journal of Medicine in 2018, “All-cause and cardiovascular mortality were higher in the febuxostat group than in the allopurinol group.”

Our firm is currently investigating claims of those who suffered serious side effects or the death of a loved one after taking Uloric gout medication. Those who pursue a Uloric lawsuit against drug manufacturer Takeda may be entitled to monetary compensation under theories of strict product liability.

Risks associated with Uloric

The FDA issued a new medication guide to better inform consumers about the potential risks of Uloric. While the risk of cardiovascular problems is elevated in patients with gout, the risk of actually dying from a heart-related event is higher in patients who take Uloric.

Patients are encouraged to discuss their full cardiac history with their physician and seek immediate medical care if any of the following symptoms of stroke or heart attack present:

  • Shortness of breath
  • Severe chest pain
  • Dizziness
  • Rapid or irregular heartbeat
  • Numbness in extremities
  • Trouble talking
  • Sudden headache

Serious side effects of Febuxostat

In addition to an increased risk of cardiac-related death, severe effects of Uloric may include:

  • Joint paint
  • Liver enzyme abnormalities
  • Hemorrhaging
  • Liver problems
  • Myocardial infarction

Uloric was launched in the U.S. in 2009 and since then, the medication has been tied to numerous complications and adverse side effects, ranging from heart attacks and liver damage to strokes and life-threatening hemorrhages.

Recourse for Uloric injuries and deaths

Pharmaceutical companies have a duty to adequately warn consumers about all possible risks and side effects of their medications. If it is found that Takeda had knowledge of Uloric dangers, but withheld this information to maintain profitability, the company could face tremendous liability.

Schedule a private consultation with a Uloric attorney at our firm today. After reviewing the circumstances of your case, we can determine if you have grounds for legal action.

Our primary goals are providing compassionate, personalized representation and seeking maximum damages for our clients’ injuries, pain and suffering. Call our office today to arrange a free case review.

Additional Resources:

  1. The National Law Review, Gout Treatment, Uloric, Found to Pose an Increased Risk of Death https://www.natlawreview.com/article/gout-treatment-uloric-found-to-pose-increased-risk-death
  2. RxList, Uloric (febuxostat) https://www.rxlist.com/uloric-side-effects-drug-center.htm
  3. FDA, FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat) https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-increased-risk-death-gout-medicine-uloric-febuxostat
  4. New England Journal of Medicine, Cardiovascular Safety of Febuxostat or Allopurinol in Patients with Gout https://www.nejm.org/doi/full/10.1056/NEJMoa1710895