The Uloric lawsuit claims Takeda Pharmaceuticals (the manufacturer of Uloric) not only new of the increased risk of cardiovascular-related deaths but also failed to warn patients of the increased risk of heart attacks and strokes.
The FDA has come to the conclusion that there is an increased risk of death with Uloric in comparison to Allopurinol (an alternative gout medication).
They came to this conclusion after an in-depth study and clinical trial. Of particular note, they found an increase in cardiac-related deaths, attributable to Uloric.
The FDA is now requiring Uloric prescription information to require a Boxed Warning (their most prominent warning) and is limiting the prescription of Ulric to patients who are not responding to or are experiencing severe side facts from Allopurinol.
Uloric was originally approved by the FDA in 2009 for the treatment of gout, a disease affecting approximately 8.3 million us adults. In 2009, the FDA made Takeda Pharmaceuticals aware of possible cardiovascular events patients being treated by Uloric may experience and required them to conduct a large scale clinical trial.
On March 12, 2018, the results of the trial were published in the New England Journal of Medicine. The authors of the study found a statistically significant increase in heart-related deaths compared to users Allopurinol.
The FDA lists the below as severe symptoms that require immediate medical attention.
- Chest pain
- Shortness of breath
- Rapid or irregular heartbeat
- Numbness or weakness on one side of your body
- Trouble talking
- Sudden severe headache
If you or a loved one are taking Uloric and experiencing any of the above, you should seek immediate emergency medical help.
If you or a loved experienced a heart attack or stroke while taking Uloric, you may be entitled to compensation. Call us today to schedule a free case evaluation with a member of our legal team. Or contact us through our form below.