Have you or a relative been diagnosed with gout (a painful type of arthritis) and have been prescribed the gout medication Uloric? In January 2019, the U.S. Food and Drug Administration (FDA) issued a black-box warning on Uloric Medication, meaning that the risks of the drug’s damage to gout patients may outweigh the benefits of taking it. Uloric has been linked to an increased risk of cardiovascular issues and death. This fact also means that if you are taking Uloric and have suffered harm because of it, you may have the right to compensation through a Uloric lawsuit.
What is Uloric?
Uloric, (also known as Febuxostat) is a medication prescribed for the treatment of gout. When a person has gout, uric acid deposits form needle-like crystals in the joints. These deposits can cause inflammation. A doctor prescribes Uloric to reduce the acid, which reduces inflammation and other symptoms associated with gout.
In February 2009, Takeda Pharmaceuticals, the medication’s manufacturer, introduced Uloric on the market. Uloric became the first gout medication on the market in more than 40 years. From 2012 to 2017, Takeda reported approximately $1.9 billion in sales of Uloric. It became one of the most prescribed brand-name medications in 2015.
Although Uloric was approved in 2009, the FDA’s approval came with one condition: Takeda was to conduct a large postmarket safety clinical trial. The clinical trial was to involve 6,000 Uloric users.
The study found that 15 gout patients who took Uloric out of every 1,000 patients suffered health-related injuries. This means that approximately 90 out of the 6,000 study participants suffered health-related issues because they took Uloric. In addition, approximately 26 study participants died for every 1,000 participants in a year. These results were compared to 22 deaths per 1,000 patients treated at the same time with Allopurinol. The 22 deaths of those who took Allopurinol had gout and cardiovascular disease.
Uloric and the FDA Black Box Warning
Unfortunately, as soon as gout patients began taking Uloric, they complained of severe side effects. Research on Uloric side effects places more weight on patients’ complaints about being harmed by taking the medication. In 2018, a published FDA-mandated study compared patients taking Allopurinol to those taking Uloric. The study found a link between Uloric and cardiovascular issues. In fact, more Uloric patients suffered cardiovascular death than those in the Allopurinol group. This resulted in the FDA adding a Black Box warning to Uloric.
A Black Box warning is one of the most serious labels placed on medication by the FDA. If severe side effects continue to be reported, the FDA may issue an Uloric recall. This means Uloric will not be prescribed and will be removed from the market. Gout patients taking Uloric should seek immediate medical help if any of the symptoms occur while taking the medication:
- Shortness of breath
- Chest pain
- Irregular or rapid heartbeat
- Weakness or numbness on one side of the body
- Sudden, severe headache
- Trouble speaking
Potential Harm Caused by Taking Uloric
If you or your loved ones are taking Uloric, understand that the medication has serious risks associated with it. One serious side effect is cardiac death. Uloric could increase your risk of suffering a heart-related death such as a heart attack. In the study conducted by Takeda Pharmaceuticals with 6,000 participants, some participants suffered:
- Inadequate blood supply to their heart
- Non-fatal stroke
- Non-fatal heart attack
In these situations, emergency surgery was often needed.
Another side effect is kidney failure. Prior to September 2017, the manufacturer didn’t include dosing recommendations for patients who suffered from gout and severe kidney impairment. It wasn’t until more patients complained of renal injuries that the manufacturer included recommendations. The current labeling limits dosing up to 40 mg a day.
Uloric Lawsuit Against Takeda Pharmaceuticals
You’re able to sue a manufacturer if you or someone you know has used a product that the manufacturer has on the market that causes harm or death. You can file a lawsuit to recoup money for your injuries such as lost wages, medical bills, and pain and suffering.
However, every plaintiff must prove specific elements to win their defective product lawsuit. These four elements for a Uloric case are the same for every defective product case. They are:
- Uloric had a defect such as causing heart or kidney issues.
- The medicine’s defect caused an injury or death.
- Uloric was taken correctly as prescribed.
- The medication was used as intended by the manufacturer.
In many defective product cases, a plaintiff isn’t required to prove a manufacturer was negligent in some way. In other personal injury cases, the plaintiff must prove that the defendant was negligent enough to win. However, strict liability holds the manufacturer responsible for harm caused by the defective product. So whether Takeda Pharmaceuticals didn’t know Uloric would cause harm to patients is irrelevant. The company is still responsible for the harm caused to patients.
Contact The Eichholz Law Firm Regarding Your Potential Uloric Lawsuit
Our knowledgable drug injury lawyers have years of combined experience in dealing with pharmaceutical companies and their dangerous drugs. If you have suffered health injuries, financial loss, and emotional damage because of taking Uloric medication, you may be entitled to compensation for your pain and suffering. Suing a drug manufacturer is a complicated personal injury case. You need a tough, experienced law firm to represent you.
At The Eichholz Law Firm, we are dedicated to the pursuit of financial justice for you and/or your loved one. We proudly offer free case reviews, so contact us today or fill out our online application. We are here to help you get the financial justice you need to overcome the harm done to you.