Uloric was FDA-approved in 2009 to treat a type of arthritis called gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Uloric works by lowering uric acid levels in the blood. Gout is a chronic disease that affects approximately 8.3 million adults in the U.S.
Although Uloric was approved in 2009, the FDA stated that “Clinical trials of Uloric identified a possible signal of serious cardiovascular outcomes, with a higher rate of serious cardiovascular outcomes, including cardiac deaths, myocardial infarctions, and strokes, in patients treated with Uloric than in the control group.” In the approval letter, Takeda was required to perform clinical trials to assess these risks.
In February of 2019, the FDA released the following safety announcement:
“The U.S. Food and Drug Administration (FDA) has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric.
As a result, we are updating the Uloric prescribing information to require a Boxed Warning, our most prominent warning, and a new patient medication guide. We are also limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol.”
Prior to the 2019 FDA announcement, in March of 2018, The New England Journal of Medicine published the results from a clinical trial performed by Takeda, the makers of Uloric. They had also concluded “In patients with gout and major cardiovascular coexisting conditions, febuxostat was noninferior to allopurinol with respect to rates of adverse cardiovascular events. All-cause mortality and cardiovascular mortality were higher with febuxostat than with allopurinol.”
Uloric Linked to Higher Risk of Cardiovascular Complications
- Cardiac Death
- Myocardial Infarction (Heart Attack)
- Stroke
Possible Serious Side Effects of Uloric
Patients should tell your health care professional if you have a history of heart problems or stroke and discuss the benefits and risks of using Uloric to treat your gout. Seek emergency medical attention right away if you experience the following symptoms while taking Uloric:
- Chest pain
- Shortness of breath
- Rapid or irregular heartbeat
- Numbness or weakness on one side of your body
- Dizziness
- Trouble talking
- Sudden severe headache
Uloric Litigation
Currently, lawyers are gathering information for possible lawsuits going forward. There have not been any patient settlements or cases that have gone to trial at this point.
However, A whistleblower case was initiated in 2010 by Dr. Helen Ge, a former Takeda Pharmaceutical safety consultant. She alleged that Takeda “failed to report to the FDA a number of post-marketing adverse events for four subject drugs” and to “adequately change the package insert warnings”. One of the referenced drugs was Uloric. The case was dismissed in 2012 and an appeal denied in 2014.
Medical References:
- https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-increased-risk-death-gout-medicine-uloric-febuxostat
- https://www.nejm.org/doi/full/10.1056/NEJMoa1710895
- https://www.hindawi.com/journals/ijr/2019/1076189/
Legal References:
- https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021856s000_Approvable.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021856s000ltr.pdf
- http://media.ca1.uscourts.gov/pdf.opinions/13-1088P-01A.pdf