Gout is a common and painful type of arthritis that affects more than 8 million Americans. Yet, there are few medications available to treat this disease. In 2009 a new drug to treat gout, known as Uloric or Febuxostat, was approved by the Food and Drug Administration (FDA). The drug was only approved after it had previously been denied FDA approval in 2005 and 2006 because the agency sought additional information on the medication’s cardiovascular risks.
How Uloric Works
Uric acid develops from purines and it is normally found in the blood. A condition known as hyperuricemia occurs when a person’s uric acid level is higher than normal. When there is too much uric acid in the blood, the high uric acid level can gather in your joints, crystalize, and cause gout.
Uloric is an oral medication that is taken once a day by some adults to treat hyperuricemia. The medication is a xanthine oxidase inhibitor that lowers blood uric acid levels by preventing purines from developing into uric acid.
Uloric Clinical Trial Results
When the FDA first approved Uloric in 2009, it acknowledged that cardiovascular risks were a possibility and required Takeda Pharmaceuticals, Uloric’s manufacturer, to do a large post-market safety clinical trial. More than 6,000 patients with gout were part of the study which found that there was an increased risk of death for patients taking Uloric. Specifically, the study found:
- 15 out of every 1,000 patients taking Febuxostat for a year died from heart-related causes compared to 11 out of every 1,000 patients taking allopurinol.
- 26 out of every 1,000 patients taking Febuxostat for a year died from any cause compared to 22 out of every 1,000 patients taking allopurinol.
The results of the study were published in the March 2018 edition of The New England Journal of Medicine.
FDA Warns of Uloric Cardiovascular Deaths
In February 2019, the FDA made a significant announcement about Uloric. After a thorough review of the clinical safety trial described above, the agency found that patients who took Uloric had a higher risk of death than patients who took another form of gout medication known as allopurinol.
Accordingly, the FDA:
- Added a boxed warning to Uloric
- Updated the Uloric patient medication guide
- Limited Uloric’s approval to patients who were not helped by allopurinol or who experienced significant side effects while on allopurinol
The FDA was petitioned to pull Uloric off the market. However, the FDA rejected this request citing limited treatment options for gout and concluding that there may still be some patients for whom the benefits of Febuxostat outweigh the risks.
Symptoms of a Cardiovascular Emergency
Patients are encouraged to tell their healthcare providers about any history of heart disease or stroke. Additionally, patients who take Uloric are encouraged to get emergency medical attention if they experience any of the following symptoms:
- Chest pain
- Shortness of breath
- Rapid or irregular heartbeat
- Numbness or weakness on one side of the body
- Dizziness or fainting
- Difficulty talking
- Blurry vision
- Sudden and severe headache
Healthcare providers should make sure patients understand the cardiovascular risks associated with Uloric and review the symptoms listed above so that patients know when to seek emergency care.
People who suffered serious cardiovascular problems while taking Uloric and people whose loved ones died from cardiovascular events while taking Uloric may have legal claims against Takeda Pharmaceuticals. A serious cardiovascular event may include:
- Heart attack
- Deep vein thrombosis
- Pulmonary embolism
- Any heart-related death
Uloric was prescribed millions of times from the time it was approved as a gout treatment in 2009 until the FDA issued its warning in 2019. Patients did not know the risk they faced. If you have been hurt, or your loved one has died, from Uloric related heart conditions, then now is the time to talk to a mass tort lawyer. As of the spring of 2019, these cases are just getting started.
If you were hurt, or a loved one died, after taking Uloric then we encourage you to contact us today for a free, no-obligation consultation about your potential recovery. Your time to file a lawsuit is limited, and we can make sure that all of your legal rights are protected.