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Uloric Lawsuit

Uloric Lawsuit

Takeda Pharmaceuticals is facing lawsuits from people who took the gout medication Uloric and suffered side effects, such as a heart attack, stroke, renal failure, or kidney disease.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Uloric induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a heart attack, stroke, or renal failure, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

What is the Problem?

Takeda Pharmaceuticals started selling Uloric in 2009, after the FDA twice rejected Uloric’s approval in 2005 and 2006 due to worries about cardiovascular side effects. In just 5 years on the market, Takeda made nearly $2 billion in sales of Uloric.

Uloric quickly became a billion-dollar blockbuster drug because Takeda claimed that Uloric was better than cheap generic gout medications like allopurinol. Instead, experts now know that Uloric is linked to a significantly higher risk of heart attacks, strokes, and death.

Uloric Lawsuits

Dozens of Uloric lawsuits have been filed by people who accuse Takeda of putting profits over safety by failing to warn about deadly side effects. The plaintiffs say they would have a safer and cheaper gout medication like allopurinol if Takeda had warned them about the risk.

Uloric Side Effects

Uloric Linked to Higher Risks vs. Allopurinol

Gout is an extremely painful form of arthritis, but effective medications have existed for over 50 years. In 2009, Takeda released Uloric, an expensive new treatment for gout.

To convince doctors to switch patients to Uloric, Takeda insisted that Uloric was better than allopurinol because it was easier on the kidneys and could be taken as a once-daily pill.

Instead, after 10 years on the market, Uloric was linked to significantly higher rates of heart attack, stroke, and death compared to allopurinol. The FDA is now warning doctors not to give Uloric to patients unless allopurinol does not work.

Canada Updates Safety Warnings for Uloric

In November 2019, Health Canada issued a Safety Warning after a major study found that 4.3% of patients on Uloric died of a heart attack or stroke.

Woman From Illinois Files Uloric Lawsuit

In November 2019, a lawsuit was filed in Illinois by a Shelly O., a woman who started taking Uloric in 2012 for gout. Four years later, she developed severe heart problems, chest pain, multiple-vessel coronary artery disease, and required surgery.

Uloric Gets “Black Box” Warning Label for Risk of Death

In February 2019, the FDA  issued a Drug Safety Communication to warn about an increased death associated with Uloric, compared to another gout medication called allopurinol (Zyloprim and Aloprim). The FDA ordered drug-makers to add a “Black Box” warning label about severe side effects, such as thrombotic strokes and heart attacks.

What is the Risk?

The increased risk of death includes heart-related deaths, such as heart attacks and strokes, as well as death from all other causes. The FDA has also limited the approved indications for Uloric, urging doctors to prescribe it only as a last resort, if other gout medications do not work.

FDA Updates Warnings on Uloric

This FDA warnings were based on an in-depth review of data that Takeda provided from a clinical trial, which found an increased risk of death with Uloric, as well as a large number of reports of patients who developed heart problems.

What Should I Do?

Patients on Uloric should tell their doctor about any history of heart problems or stroke. Seek emergency medical attention right away if you experience the following symptoms while taking Uloric:

  • Chest pain
  • Shortness of breath
  • Rapid or irregular heartbeat
  • Numbness or weakness on one side of your body
  • Dizziness
  • Trouble talking
  • Sudden severe headache

What is a Thrombotic Stroke?

A thrombotic stroke occurs when a blood clot clogs a blood vessel in the brain and cuts off circulation to that part of the brain. The symptoms depend on which part of the brain is not receiving blood-flow. The most serious strokes occur when blood clots get stuck in large arteries that supply blood to bigger parts of the brain.

What is a Heart Attack?

A heart attack or “myocardial infarction” occurs when a blood clot clogs a vessel that supplies blood to the heart muscle. If blood-flow is not restored quickly, the heart muscle begins to die. Every year, about 1 million people in the U.S. suffer a heart attack, and 50% of them die.

Uloric and Renal Failure

Uloric is removed from the body through the kidneys and liver. Unfortunately, it has not been studied in patients with end-stage kidney impairment or patients on dialysis. The label recommends limiting the dosage of Uloric to 40-mg once a day in patients with severe renal impairment.

Study Links Uloric and Increased Kidney Injury Risk

In November 2019, a post-marketing safety study found that Uloric was significantly more likely to be associated with kidney disease compared to other gout medications. Uloric was linked to a 5.7-fold higher risk of kidney injury. Overall, 7% of Uloric patients died after developing a kidney injury.

The study, “Acute kidney injury associated with febuxostat and allopurinol: a post-marketing study” was published in the journal Arthritis Research & Therapy in November 2019.

Gout and Kidney Failure

People with gout are more likely to develop renal failure (also called “kidney failure”) due to uric acid crystals in the blood. As the kidneys filter the blood, these crystals damage the kidneys and cause scarring. If left untreated, gout can lead to serious kidney problems that require dialysis or a transplant.

Symptoms of Renal Failure

  • Less urine or too much
  • Swelling in the legs, ankles, and feet
  • Fluid retention
  • Unexplained shortness of breath
  • Drowsiness
  • Nausea and loss of appetite
  • Confusion

How Does Uloric Work?

Uloric (febuxostat) is a medication used to treat gout, which is a debilitating type of arthritis that occurs when uric acid builds up in the blood and causes inflammation in the joints. Uloric treats gout by inhibiting the enzyme xanthine oxidase, which reduces the amount of uric acid in the body.

Takeda Earned $1.9 Billion on Uloric in 5 Years

Uloric is manufactured by Takeda Pharmaceuticals, a Japanese-based pharmaceutical company. When it was approved by the FDA in 2009, it was the first new gout drug in over 40 years. Uloric is a blockbuster drug, raking in $1.9 billion in U.S. sales from fiscal years 2012 through 2017.

Takeda Hit With Whistelblower Lawsuit for Uloric

In January 2012, Takeda Pharmaceuticals was hit with a whistleblower lawsuit filed by Dr. Helen Ge, a former safety consultant for Takeda who alleged that the company withheld risk information about dangerous side effects, including renal failure, bone marrow failure, drug interactions, and more.

Uloric Recall

Uloric has not been recalled in the U.S. However, Public Citizen and other consumer-safety groups have demanded a Uloric recall. The FDA has decided to allow it to stay on the market, but with stronger warning labels and more-limited approved uses.

Can I Join a Uloric Class Action?

Instead of a class action lawsuit, our lawyers are filing individual lawsuits for people who suffered from heart problems, stroke, heart attack, or renal failure (kidney failure) after using Uloric.

If you were diagnosed with any of these side effects, we may be able to help you file a lawsuit and seek justice for your pain and suffering, medical expenses, long-term injuries, wrongful death of a loved one, and more.

Do I have a Uloric Lawsuit?

The Schmidt Firm, PLLC is currently accepting Uloric induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a heart attack, stroke, or renal failure, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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