By Sandra Dalton, Staff Writer
Uloric (febuxostat) is used to treat gout. In February 2019, after reviewing the results of a safety study, the U.S. Food and Drug Administration (FDA) issued a safety announcement warning that Uloric increase the risk of cardiovascular events and death and added a black box warning to the Uloric label. Uloric users who have been harmed and loved ones of those who have died as a result of taking Uloric are seeking compensation from Takeda Pharmaceuticals for the harm they have suffered, alleging that the company failed to warn and hid the dangers of the dangerous drug.
Uloric More Likely to Cause Cardiac Events and Death than Competitor
The results of the CARES clinical trial were published in the New England Journal of Medicine in March 2018. Takeda was required by the FDA to conduct the trial to compare the safety of Uloric with another gout medication called allopurinol. Researchers looked at 6,190 patients and found that both cardiovascular deaths and overall deaths were higher in patients taking febuxostat than allopurinol:
- Febuxostat – 15 heart-related deaths per 1,000 patients and 26 deaths from all causes per 1,000 patients
- Allopurinol – 11 heart-related deaths per 1,000 patients and 22 deaths from all causes per 1,000 patients
Based on its review of the trial the FDA required a black box warning and limited its approved use Uloric to “certain patients who are not treated effectively or experience severe side effects with allopurinol.”
Patients who have been harmed by Uloric and those who have lost loved ones are seeking compensation from Takeda claim that the company should have warned doctors and users about the cardiovascular risks much sooner. The FDA rejected the drug in 2005 and 2006, asking for more data on the cardiovascular risks. When it approved the drug in 2009, it required Takeda to launch the CARES safety trial and to include a warning about cardiovascular thromboembolic events on the label.
Those who may be able to recover compensation include Uloric users who have suffered:
- Heart attack
- Blood clots
Loved ones of patients who have died as a result of cardiac events while taking Uloric may be able to recover wrongful death compensation.
Whistleblower Lawsuit Says Takeda Hid Dangers
A 2011 whistleblower lawsuit claimed that Takeda hid reports of severe drug interactions when Uloric was taken with warfarin, fatal interactions when the drug was taken with autoimmune treatments, and failure to report adverse events to the FDA. Dr. Helen Ge, the former Takeda contractor who filed the suit, also said that the company knew that Uloric had made kidney problems worse in some patients. She said she was fired after urging Takeda to report the adverse events to the FDA.
If you believe that you or a loved one has been harmed by Uloric, you can learn more about your rights and how you can recover damages for your losses by searching our directory to find a lawyer near you.