Uloric - Consumer Justice Foundation

Patients with gout taking Uloric to manage their hyperuricemia may be significantly more likely to suffer severe adverse cardiovascular events or heart-related death.  

Uloric is one of the few available medications approved to treat hyperuricemia, or excessive levels of uric acid in the blood, associated with gout. Gout is a chronic disease that affects millions of Americans and over the past decade, doctors have prescribed Uloric millions of times. Unfortunately, studies have shown that people who take Uloric may face an increased risk of suffering severe adverse cardiovascular events like heart attack or stroke, or possibly even death. Any patients who took Uloric for gout and subsequently developed cardiovascular problems may have a defective drug claim against Takeda Pharmaceuticals. Additionally, any close family members who had loved ones pass away from fatal heart-related side effects may be able to sue Takeda for wrongful death. Contact Consumer Justice Foundation today to find out how our consumer advocates can help.

Uloric Alternatives for Gout

There aren’t many medications on the market that have been approved to treat gout, so patients diagnosed with gout may feel like they have no option but to choose between Uloric, which is tied to heart attack, stroke and heart-related death risks and which the FDA says should no longer be recommended as a first-time treatment for gout, or allopurinol, which has been linked to severe, potentially life-threatening skin reactions and liver failure in users. Gout is a painful, chronic inflammatory condition caused by excessive levels of uric acid in the blood and there are some natural remedies that gout sufferers may be able to try as an alternative to Uloric or other potentially dangerous gout medications. Some possible Uloric alternatives for gout include the following:

  • Avoiding foods with purines – Purines are substances found in animal and plant foods that the body coverts to uric acid. By avoiding foods with purines, you may be able to naturally lower your body’s uric acid levels.
  • Drinking gingerroot tea – Gingerroot has natural anti-inflammatory properties that may help relieve pain associated with arthritis or gout.
  • Reducing alcohol consumption – Excessive alcohol intake can interfere with uric acid clearance and is therefore a risk factor for gout. Reducing your alcohol consumption is one lifestyle change that may help alleviate your gout pain.
  • Maintaining a healthy weight – Being overweight or obese is another major risk factor for gout. By eating well and maintaining a healthy weight, you may be able to minimize gout flareups without taking medication.
  • Eating more lemons and cherries – Lemons are a significant source of Vitamin C, which is known to neutralize uric acid, and cherries contain anthocyanin and bioflavonoids, which can help relieve pain associated with arthritis.

What is Uloric?

A prescription medication used to treat gout that has been linked to an increased risk of cardiovascular injuries and heart-related deaths.

Uloric (febuxostat) is a drug commonly prescribed for the chronic management of hyperuricemia (excessive levels of uric acid in the blood) in patients with gout. Gout is a form of inflammatory arthritis caused by a buildup of uric acid crystals in the joints. The most common symptoms of gout include severe pain, stiffness and swelling in the affected joints and the condition frequently affects the joint in the big toe. Patients with gout may be prescribed oral medications like Uloric to lower their uric acid levels and help relieve their symptoms. Uloric belongs to a class of drugs called xanthine oxidase (XO) inhibitors, which work by inhibiting the enzyme xanthine oxidase, a crucial component in the chemical reaction that produces uric acid in the body. By inhibiting this enzyme, Uloric causes the body to produce less uric acid and can help relieve the inflammation and pain associated with gout. Uloric was approved by the U.S. Food and Drug Administration (FDA) in 2009 and is manufactured by Takeda Pharmaceuticals.

Potential Side Effects of Uloric

When Uloric was approved by the FDA in 2009, it became the first prescription drug in 40 years to be approved to treat hyperuricemia in adults with gout, and it quickly became the first line of treatment for the painful condition. More than ten years later, we now know that patients taking Uloric to treat their gout may face an increased risk of serious, potentially life-threatening injuries and complications. If you are taking Uloric to reduce your blood uric acid levels because you have gout, you could be at risk for the following cardiovascular events:

  • Heart attack
  • Stroke
  • Deep vein thrombosis
  • Pulmonary embolism
  • Unstable angina
  • Heart-related death

Link Between Uloric and Heart Attacks, Deaths

Before approving Uloric in 2009, the FDA rejected the drug on two different occasions – in 2005 and in 2006 – both times asking for more data on the cardiovascular risks associated with the gout drug. When the FDA eventually approved Uloric, it was on the condition that Takeda conduct a post-marketing study to evaluate cardiac outcomes in patients taking the gout medication. In March 2018, the New England Journal of Medicine published the results of the clinical trial, called Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Comorbidities (CARES), which showed that patients taking Uloric to treat their gout faced an increased risk of cardiac death. It wasn’t until February 2019, 10 years after Uloric first entered the market in the United States, that the FDA finally added a Boxed Warning to the Uloric label, a move the agency said was “based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric.”

Lawsuits Against Uloric for Injuries

Attorneys across the country are investigating Uloric injury lawsuits on behalf of plaintiffs who claim that they suffered cardiovascular problems after taking Uloric, including heart attack, stroke, pulmonary embolism and deep vein thrombosis. Uloric wrongful death lawsuits are also being pursued by the loved ones of former Uloric users who died from cardiovascular problems allegedly caused by Uloric. Prior to the Uloric cardiovascular injury and wrongful death lawsuits, a whistleblower lawsuit was filed by a former Takeda consultant in 2011, claiming that the drug maker deliberately concealed serious adverse side effects associated with Uloric and two other drugs, Prevacid and Dexilant, and fired her when she recommended that Takeda report the adverse events to the FDA.

Uloric FDA Warnings

November 2017 – Based on a preliminary analysis of the CARES trial, the FDA issues a drug safety communication warning that Uloric is associated with an increased risk of heart-related death, compared to another gout drug called allopurinol (Zyloprim or Aloprim).  

June 2018 – The consumer advocacy group Public Citizen files a citizen petition, calling for the FDA to remove Uloric from the market. The petition states, among other things, that “There is overwhelming evidence that the serious cardiovascular harms of febuxostat outweigh any purported clinical benefit.”

January 2019 – The FDA holds a joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the potential danger Uloric may pose to users. Most of the committee members agree that Uloric treatment should be limited to patients who cannot tolerate allopurinol and that Uloric should not be used in the general population or be designated as a first-line therapy for gout.

February 2019 – The FDA updates its 2017 Uloric safety communication, indicating that patients taking Uloric face an increased risk of death. The agency adds a Boxed Warning to the Uloric label and limits the approved use of Uloric to patients for whom treatment with allopurinol is ineffective or inappropriate.

February 2019 – The FDA denies Public Citizen’s petition, stating that “Because of the limited treatment options available for gout and the risks associated with them, there are patients for whom the benefits of febuxostat outweigh the risks.”

Studies Linking Uloric to Side Effects

March 2018 – The New England Journal of Medicine publishes the results of the Uloric clinical trial, revealing a statistically significant increased risk of death linked to the widely used gout medication. According to the study authors, “Cardiovascular death and deaths from any cause were more frequent in the febuxostat group than in the allopurinol group.

February 2019 – A study published in the International Journal of Rheumatology finds that, compared with other serum urate-lowering treatments, febuxostat may increase the risk of cardiovascular death.

Why We Think the Manufacturer of Uloric Should Be Held Liable

By the time the FDA added new warnings to the Uloric label and restricted the drug’s use, it had already been on the market for 10 years and been prescribed to millions of patients with gout. Had Takeda included proper warnings about the potential for Uloric to cause cardiovascular side effects or heart-related death in users from the very beginning, Uloric users could have made an informed decision about whether the potential risks of the gout medication outweighed the possible treatment benefits. As more information comes to light about the link between Uloric and serious cardiovascular events, including heart-related death, a growing number of Uloric lawsuits are being brought against Takeda Pharmaceuticals, alleging that:

  • Takeda failed to adequately research the safety of its gout medication
  • Takeda knew that about the risks associated with Uloric
  • Takeda failed to properly disclose the risk of heart-related side effects from Uloric
  • The potential risk of cardiac death from Uloric outweighs any possible treatment benefit
  • Takeda aggressively marketed Uloric to patients who were unaware of the potential risks of the drug

What should you do? If you have suffered a heart attack or lost a loved one because of alleged Uloric side effects, you should contact a lawyer as soon as possible to discuss filing a Uloric lawsuit.

According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 8.3 million Americans suffer from symptoms of gout and the majority of gout cases are treated with medications, like Uloric. Uloric lawsuits filed against Takeda Pharmaceuticals claim that the drug maker knew about the potential for Uloric treatment to cause side effects like cardiovascular problems or heart-related death and failed to disclose these risks to the public. If you or someone you love suffered serious heart-related side effects allegedly resulting from Uloric use, our consumer advocates at the Consumer Justice Foundation can help. We are committed to protecting the rights of consumers harmed by dangerous or defective medications and we can help put you in touch with an attorney who specializes in defective drug cases. With a knowledgeable Uloric injury attorney on your side, you can ensure that your legal rights are protected and seek fair and timely compensation for the alleged injuries and losses you have suffered from Uloric.

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