The FDA has slapped a black box warning on Takeda’s relatively new gout medicine, Uloric (Febuxostat), based on reports that the drug is linked to an increased risk of cardiac-related death compared to older gout treatments.
Uloric linked to cardiac-related deaths
Uloric is manufactured by Japanese drug maker Takeda, and was approved for sale in the United States in 2009. According to Fierce Pharma, the FDA denied Uloric’s approval not once, but twice in 2005 and 2006, due to cardiovascular side effects found in clinical safety trials. Health regulators finally green-lighted Febuxostat, but did add language about possible cardiovascular problems in the drug’s Warning and Precaution labeling. A pre-market clinical trial had demonstrated that patients who took Uloric experienced higher rates of cardiovascular problems such as heart attacks and strokes versus those who took the gout drug Allopurinol.
As Uloric hit the market, Takeda was required to perform a large post-market study to confirm the safety of its gout medicine, and an in-depth review of the results are what prompted this black box warning – the FDA’s most stringent.
Clinical trial prompts black box warning
In Takeda’s clinical trial, which included nearly 6,200 patients, patients were given either Uloric or Allopurinol. The findings showed that patients who took Uloric were significantly more likely to suffer a heart-related death or death from other causes.
Health officials now advise patients who are taking Uloric for the treatment of gout to be alert for possible cardiac-related problems, and to seek immediate medical care if they experience:
- Numbness on one side of the body
- Shortness of breath
- Severe headache
- Chest pain
- Difficulty talking
- Irregular or rapid heartbeat
The FDA notes that health care providers and medical professionals should consider Uloric heart risks when deciding whether to prescribe their patients Febuxostat. The black box warning on Uloric side effects may dent Takeda’s earnings on the drug, which topped more than $365 million in less than one year.
Some 8.3 million Americans suffer from gout, a chronic type of arthritis for which there are few available treatments.
Pending litigation over Uloric side effects
All patients deserve adequate warnings about medication side effects and risks. Those who took Uloric before the Black Box Warning may not have not been aware about the cardiovascular deaths linked with the drug.
If you or someone you love suffered a heart attack, stroke or other cardiovascular problems after taking Uloric, you may be entitled to legal compensation.
Contact Showard Law Firm for a free case review to determine if you are eligible to file a lawsuit against Takeda. Our firm has a proven track record of advocating for clients who suffered from the effects of defective drugs, and has built a reputation as an aggressive opponent against Big Pharma.
Additional Resources on Gout Mediction Death Risks:
- Medical Xpress, FDA: Gout drug uloric increases risk of death https://medicalxpress.com/news/2019-02-fda-gout-drug-uloric-death.html
- FDA, Uloric (febuxostat): Boxed Warning Added – Due to Increased Risk of Death with Gout Medicine https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm631824.htm
- FiercePharma, Takeda gout drug Uloric loses first-line approval after FDA confirms death risks https://www.fiercepharma.com/pharma/takeda-s-uloric-suffers-fda-safety-setback-report-increased-death-risks