Joanna Szabo  |  July 23, 2020

Category: Heart Health

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close up of person hands taking gout medication

In February 2019, the U.S. Food and Drug Administration issued a new boxed warning after studies showed Uloric gout medication poses an increased risk of death and could be a factor that causes heart attacks.

What is an FDA Boxed Warning?

The boxed warning is the most prominent and serious warning provided by the FDA. It appears on the package insert for certain prescription drugs with a box around it to draw attention to drug dangers and potential high risk side effects.

When Was Uloric FDA-approved?

Uloric (febuxostat) was approved by the FDA in 2009 for the treatment of gout.

What is Gout?

Gout is a form of arthritis caused by a buildup of too much uric acid in the blood. As a result, excess uric acid may settle in the joints where it crystallizes and causes gout, the painful joints associated with this type of arthritis.

The crystallization of uric acid in joints may cause a variety of symptoms such as pain, tenderness, redness, warmth, and swelling. These symptoms typically affect the joint found at the base of the big toe, but the condition can affect other joints like the ankles, knees, elbows, wrists, and fingers.

Like other forms of arthritis, gout may come in flares. Symptoms can come out of nowhere and commonly start at night. For the first four to 12 hours of a flare, pain may be more severe before subsiding to lingering discomfort. This lower pain can stick around for a few days up to a few weeks.

How Does Uloric Work?

Uloric works by reducing uric acid levels in the blood, and as a result, controls gout.

What Is Uric Acid and Where Does it Come From?

Uric acid is a waste byproduct of the body’s cells and a natural component of urine. Higher than normal uric acid levels may occur when the kidneys don’t eliminate uric acid efficiently.

What Is a Normal Level of Uric Acid?

A healthy uric acid level is between 2.4 to 6.0 mg/dL in women and between 3.4 to 7.0 mg/dL in men. Hyperuricemia is when there is an abnormally high level of uric acid in the blood.  Higher than 7.0 may result in the development of gout or uric acid-based kidney stones.

What Are the Side Effects of Uloric?

Taken orally, Uloric is associated with a variety of common side effects, including nausea. Liver functioning may also be impaired while taking Uloric.

The drug is reportedly also associated with liver disease, which can be fatal, and an increase in liver enzymes. Symptoms of liver disease include persistent nausea, stomach or abdominal pain, dark urine, and yellowing of the eyes and skin.

Side effects such as pink or bloody urine and painful urination are also reported and may be signs of a more severe problem. The development of a rash could also be the sign of a severe reaction and should reportedly be treated promptly.

Other patients may experience initial flare-ups of gout upon starting a regimen of Uloric.

If a patient is allergic to Uloric, they should not take the drug. An allergic reaction may include fever, swollen lymph nodes, rash, itching, swelling (especially of the face, tongue, and throat), severe dizziness, and trouble breathing. Serious skin and allergic reactions may affect the liver, kidneys, heart, and lungs.

Is Uloric a Medicine That Causes Heart Attacks?

older man with medication having chest painsThe FDA found that the results of a safety clinical trial conducted by Uloric’s manufacturer, Takeda Pharmaceuticals, showed that patients taking Uloric had an increased risk of heart-related complications and death from all causes when compared to patients who took the competitor drug allopurinol.

When Uloric was first approved, it was initially considered to be safer than allopurinol because comparatively very little of the drug is excreted through the kidneys. Moreover, Uloric only required patients to take one pill a day, making it more convenient for many patients. However, there may be considerable risks linked with the newer gout medication, including heart attacks and other cardiovascular issues.

When Uloric was FDA-approved in 2009, the FDA included a Warning and Precaution about potential cardiovascular problems in patients taking Uloric.

A decade later, in Feb. 2019, the FDA concluded that “there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol.” The finding led the agency to update the drug’s prescribing information, as well as to require the Boxed Warning about potential cardiovascular issues.

Why Did Takeda Conduct a Post-Market Safety Clinical Trial?

The FDA required Takeda to take the post-market safety clinical trial to prove Uloric efficacy against allopurinol. The study included more than 6,000 patients diagnosed with gout who received either Uloric or allopurinol to treat the condition. The study is known as the CARES trial (Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities).

How Does Uloric Compare with Allopurinol?

The FDA notes that in the CARES trial, Uloric did not increase the risk of a combination of heart-related death, non-deadly heart attack, non-deadly stroke and unstable angina compared to allopurinol, but when the outcomes were examined separately, Uloric was found to have an increased risk of heart-related complications, heart-related deaths, and death from all causes.

Who Should Take Uloric?

The FDA recommends that only patients who have failed to find relief using allopurinol or those who cannot tolerate allopurinol be placed on a regimen of Uloric.

It’s not known whether Uloric causes heart attacks, but patients taking Uloric can have serious heart-related issues, including Uloric heart attacks, strokes, and heart-related deaths.

Chest pain, shortness of breath, dizziness, numbness on one side of the body, sudden trouble talking or extreme headache may be indications of severe heart issues.

Filing an Uloric Lawsuit

A growing number of patients are coming forward with allegations of heart attacks and other serious complications after taking Uloric.

If you or someone you love has suffered from side effects of Uloric, including heart attacks or other cardiovascular complications, or if someone you love has died from these complications, 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 side effects of Uloric, nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting a lawyer can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.

In general, Uloric lawsuits are filed individually by each plaintiff and are not class actions.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual Uloric lawsuit or Uloric class action lawsuit is best for you. Hurry — statutes of limitations may apply.

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Join a Free Uloric Class Action Lawsuit Investigation

If you suffered from a serious side effect or a loved one died while taking Uloric, you may have a legal claim. See if you qualify to pursue compensation and join a free Uloric lawsuit investigation by submitting your information for a free case evaluation.

An attorney will contact you if you qualify to discuss the details of your potential case.

PLEASE NOTE: If you want to participate in this investigation, it is imperative that you reply to the law firm if they call or email you. Failing to do so may result in you not getting signed up as a client or getting you dropped as a client.

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