Uloric (febuxostat) is a prescription medication for the treatment of gout. Gout is a painful type of arthritis. It occurs when high levels of uric acid deposit needle-like crystals in the joints. This causes inflammation. Uloric works by reducing the acid.
Manufactured by Takeda Pharmaceuticals, Uloric first came on the market in February 2009. It was the first new gout medication in over 40 years. However, soon people began to come forward saying that Takeda was not reporting severe side effects caused by Uloric.
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.
According to a new report, since Uloric gained FDA approval, Takeda aggressively marketed and prescribed the medication to hundreds of thousands of unaware patients. Takeda reported $1.9 billion in US sales of Uloric from fiscal years 2012 through 2017. In one year, there was 1.3 million US prescription. This made it the 46th most prescribed brand-name medication in 2015.
Uloric Whistleblower Lawsuits
A former safety consultant, Dr. Helen Ge for Takeda filed a whistleblower lawsuit against the company. Dr. Ge said that the company withheld risk information regarding Uloric. She also said that Takeda failed to report that Uloric could interact with several other medications. Furthermore, she said there are serious side effects that people don’t know about including heart problems.
Uloric & Cardiac Deaths
In November 2017, the FDA issued a safety communication warning after a clinical trial showed Uloric increases heart-related deaths. This study followed 6,000 people and found that Uloric increased the chance of heart-related death, non-fatal heart attack, non-fatal stroke and a condition of inadequate blood supply. This often caused urgent surgery.
Uloric & Kidney Failure
Before September 2017, Uloric’s labeling did not include dosing recommendations for patients with severe renal impairment as Takeda insisted there wasn’t enough data for a recommendation. However, as more people came forward with injuries. The label now recommends patients with severe renal impairment be limited to a dose of 40mg once daily. The recommendation for patients with mild to moderate renal impairment continues to be the same.
Uloric & Eosinophils
Eosinophilia happens due to high eosinophils levels. Eosinophils are disease-fighting white blood cells, which normally indicates a parasitic or allergic reaction or cancer. Tissue eosinophilia can also happen. This disease can cause full-body reactions like cancer, AML, or Hodkin’s Lymphoma.
FDA Black Boxed Warning
The FDA-mandated study, published in The New England Journal of Medicine in 2018, revealed that the “treatment with Uloric resulted in overall rates of major cardiovascular events that were similar to those associated with Allopurinol treatment among patients with gout who had coexisting cardiovascular disease. However, cardiovascular death and deaths from any cause were more frequent in the Uloric group than in the Allopurinol group”. Therefore, on February 21, 2019, the FDA added a Black Boxed warning, the most serious warning, to the medication Uloric.
Patients are urged if seek medical attention if he or she experiences:
- Chest pain
- Shortness of breath
- Rapid or irregular heartbeat
- Numbness or weakness on one side of your body
- Trouble talking
- Sudden severe headache
Uloric’s Faulty Study
The FDA approved Uloric under the condition that Takeda performs a large postmarket safety clinical trial involving over 6,000 users. The results from the trial showed that overall, Uloric did not increase heart events compared to the current most used medication on the market. However, when researchers examined the individual side effects, 15 Uloric users suffered health-related injuries out of every 1,000 patients. In addition, there were 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol.
When manufacturers produce unsafe products that create pain and suffering, you deserve compensation. Although no amount of money will change the fact that you have suffered a serious injury because of manufacturer irresponsibility, compensation will help offset your current and future medical costs, as well as provide for the pain and suffering you have experienced. By filing, you may also help protect other women and their families from needless distress.
We Want to Help Uloric Victims
Furthermore, it is your right for manufacturers to inform you about the long-term risks associated with the medical devices, and it is the responsibility of manufacturers to provide this information.
Of course, we want to help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and likewise, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. You also may be entitled to compensation for their injuries and damages. The types of losses we can help you recover include:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and Pain and suffering
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
Therefore, if the conduct of a company is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you suffered after taking Uloric, please speak to us to learn more about your rights.
The Michael Brady Lynch Firm is currently accepting cases in all 50 states. Please use the form on this page or call toll-free 24 hours a day at 877-513-9517.