In February 2019, the U.S. Food and Drug Administration required a boxed warning after concluding that Uloric gout medicine poses an increased risk of deathcompared to allopurinol.

The FDA’s boxed warning is its most prominent warning. The Uloric patient medication is being updated with the black box warning as well.

“We are also limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol,” the FDA said in a safety announcement on Feb. 21, 2019.

What is Uloric?

Uloric
is a popular gout medication first introduced to the market in 2009, joining the leading gout drug allopurinol — FDA-approved in 1996 — as a first-line treatment option, according to WebMD. In fact, Uloric was initially considered to be a safer and more convenient option than allopurinol because very little of the medication is excreted through the kidneys, it didn’t require dosing adjustments, and it only involved taking a single pill per day.

Unfortunately, Uloric has recently been connected with serious and even fatal side effects, including major cardiovascular problems.

Findings of Six-Year Study of Uloric Gout Medicine Released Last Year

Even though Uloric gout medicine has been on the market for a decade, recent studies indicate the drug may increase the risk of death in patients with heart disease.

Uloric (febuxostat) was found to increase the risk of sudden death more so than allopurinol, even though the drugs had similar risks of non-fatal heart attack, non-fatal stroke, emergency surgery for treatment of angina and death related to cardiovascular reasons.

A study known as the CARES trial (Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities), was presented at the American College of Cardiology’s 67^th Annual Scientific Session in 2018. The CARES trial involved more than 6,000 gout patients.

The study’s lead investigator and author, Dr. William B. White, also published his team’s findings in the New England Journal of Medicine last year. Takeda Pharmaceuticals, maker of Uloric, paid for the CARES clinical trial. The study was a requirement of the drug’s FDA approval in 2009.

Signs of serious cardiovascular problems can include:

• Chest pain
• Shortness of breath or breathing difficulties
• Dizziness or fainting
• Rapid heartbeat
• Irregular heartbeat
• Feeling numb or weak on one side of the body
• Slurred speech
• Sudden onset of blurry vision
• Sudden onset of severe headache

Gout is a Type of Arthritis

Gout is a type of inflammatory arthritis that develops when the blood contains an excess amount of uric acid. The extra uric acid crystallizes and settles into joints.

According to the Mayo Clinic, the big toe is the most common area for a gout attack to develop. The affected area will become severely painful, swollen and red. The pain often comes on suddenly. Some say the sensation feels like the big toe is on fire and even the weight of a sheet causes excruciating pain.

Other joints that are commonly affected include the ankles, knees, elbows, wrists, and fingers. The pain tends to be the most severe within the first four to 12 hours. As the most severe pain ebbs, a certain level of discomfort can last anywhere from a few days to a few weeks.

Nearly 8 million Americans suffer from gout. Risk factors include:

• A diet rich in meat and seafood
• Drinking fructose-sweetened beverages
• Drinking alcoholic beverages, especially beer
• Medical conditions such as high blood pressure, diabetes, metabolic syndrome, and heart or kidney disease
• Family history of gout
• Certain medications, including thiazide diuretics taken for high blood pressure, low-dose aspirin, and anti-rejection drugs taken by patients who have received an organ transplant.

Filing an Uloric Lawsuit

If you or someone you love has suffered or died from Uloric cardiovascular problems, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot take away the pain and suffering caused by Uloric side effects, nor can it bring a loved one back to life, but it can at least help alleviate the financial burden incurred by medical expneses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, especially in the midst of dealing with medical complications or the loss of a loved one, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.