Uloric Lawsuit | 2025 Latest Updates

Uloric Lawsuit Overview

An individual is enduring severe pain and swelling from Gout in the big toe and right foot area.

Uloric (febuxostat) lawsuits have been filed against Takeda Pharmaceuticals America Inc. on behalf of patients who suffered serious injuries after taking this gout medication. The primary allegations focus on Takeda’s failure to warn about increased risks of heart attacks, strokes, and cardiovascular death.

Since entering the U.S. market in February 2009, Uloric has been linked to serious, life-threatening side effects including cardiovascular risks, kidney damage, liver failure, and more.

Latest Uloric Lawsuit Updates

• Feb 2025 – Takeda decides to discontinue Uloric in the US after years of safety concerns [1]. 
• February 21, 2019 – FDA added a Boxed Warning (Black Box Warning) to Uloric after a cardiovascular safety trial found an increased risk of heart attacks, strokes, and heart-related deaths [2].
• 2019 – A post-marketing study published in the journal Arthritis Research and Therapy found that acute renal failure was reported 5.7 times more frequently with febuxostat (Uloric) than with other similar medications [3].
• 2010 – A former Takeda Pharmaceuticals employee, Dr. Helen Ge, filed a whistleblower lawsuit alleging that Takeda withheld critical safety information about Uloric’s serious side effects. The complaint claimed that Takeda defrauded Medicare and Medicaid by failing to report that Uloric can cause severe cardiovascular events, and that they intentionally misrepresented adverse events in reports to the FDA [4].

“Takeda … intentionally misrepresented and altered the descriptions of adverse events in reports, and intentionally misclassified adverse events as ‘non-serious’ or as ‘labeled’ drug-drug interactions, to avoid filing 15-day adverse event reports.”

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What is Uloric?

Image of Uloric packaging for the dosage of 80mg tablets (also sold in 40mg tablets).

Manufactured and marketed by Takeda Pharmaceuticals, Uloric (febuxostat) is a prescription Gout drug that treats joint inflammation by reducing uric acid levels. The FDA approved Uloric in February 2009, making it the first new Gout medication Uloric to hit the U.S. market in more than four decades.

Uloric is designed to work by blocking xanthine oxidase, an enzyme needed to create uric acid levels. The medication comes in once-daily doses of 40 mg and 80 mg.

FDA Black Box Warning

Image of “Boxed Warning” on Uloric for Cardiovascular Death.

According to the U.S. Food and Drug Administration, on February 21, 2019, the agency released a Drug Safety Communication, which added a Boxed Warning (often referred to as a ‘Black Box Warning’) to the prescription medication Uloric (febuxostat).

A Black Box Warning is the most severe warning that the U.S. Food and Drug Administration requires drug manufacturers to warn patients about life-threatening side effects.

This boxed warning was issued after an in-depth review of results from a cardiovascular safety trial that found Uloric had an increased risk of heart attacks, strokes, and heart-related death.

FDA has concluded there is an increased risk of death with Uloric (febuxostat).

FDA Reports and Statistics

According to FDA findings:

• Heart-related deaths: 15 deaths from heart-related causes were observed for every 1,000 patients treated with Uloric for a year compared to 11 deaths per 1,000 patients treated with allopurinol.
• Overall mortality: 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated with allopurinol [5].
• Elevated liver enzyme levels: Occurred in 4-6% of patients treated with Uloric during pre-approval clinical trials.
• Critical liver enzyme elevation: Approximately 2% of Uloric users reported elevated liver enzymes three times the upper limit of normal.

Uloric Injuries & Side Effects

Uloric has been linked to numerous serious and potentially fatal side effects:

• Cardiovascular problems: Heart attacks, strokes, thrombotic stroke, heart-related deaths, heart disease
• Liver damage: Liver failure, elevated liver enzymes
• Kidney issues: Kidney damage, renal failure, acute kidney injury
• Blood disorders: Bone marrow failure, severe bleeding episodes
• Immune system disorders: Allergic reactions (anaphylaxis, rash, Stevens-Johnson syndrome)
• Other complications: Rhabdomyolysis, psychiatric disorders, inflammatory arthritis

“With over 8 million Americans suffering from painful, intense flareups of Gout, the potential for Uloric induced cardiovascular problems is possible.”

Do You Qualify for a Uloric Lawsuit?

You may qualify for a Uloric lawsuit if:

• You took Uloric to treat gout.
• You experienced serious side effects including heart attack, stroke, or other cardiovascular problems.
• Your injuries required medical treatment or hospitalization.
• You can provide medical documentation linking your injuries to Uloric.

Evidence Required for a Uloric Lawsuit

To support your Uloric lawsuit, you’ll need:

• Medical records showing you were prescribed and took Uloric
• Documentation of cardiovascular events or other serious side effects
• Medical evidence linking Uloric use to your injuries
• Records of treatments and medical expenses related to your injuries

Damages You Can Recover

Victims in Uloric lawsuits may be eligible to recover compensation for:

• Medical expenses related to treatment of Uloric side effects
• Lost wages due to inability to work
• Pain and suffering caused by injuries
• Punitive damages against the manufacturer

Statute of Limitations for Uloric Lawsuits

Time limits for filing a Uloric lawsuit vary by state. It’s critical to consult with an attorney as soon as possible to ensure your claim is filed within the applicable statute of limitations in your state.

See all related dangerous drug lawsuits our attorneys covered so far.

FAQs

1. What is Uloric?

Uloric (febuxostat) is a prescription gout medication manufactured by Takeda Pharmaceuticals that treats joint inflammation by reducing uric acid levels. It was FDA approved in February 2009.

2. Has Uloric been recalled?

No. There has been no Uloric recall and the medication is still available by prescription from your doctor.

3. How much does it cost to hire a Uloric lawyer?

Our lawyers offer a 100% free review of your potential case. If we decide to pursue your claim, you will owe nothing unless we obtain a clinical trial verdict or a Uloric settlement on your behalf.

4. How can I determine if my health issues are related to Uloric?

To determine if your health issues are related to Uloric, consult with your healthcare provider, review your medical history, and consider whether your cardiovascular issues began or worsened after starting Uloric.

5. What steps should be taken if I suffered health issues after taking Uloric?

If you suffered health issues after taking Uloric, seek medical attention immediately, document your symptoms and treatments, retain medical records, and consult a lawyer.

6. What evidence is needed to support a Uloric lawsuit?

Evidence needed includes medical records showing the prescription and use of Uloric, documentation of cardiovascular events, expert testimony linking Uloric to these health issues, and any communication with healthcare providers.

7. Can I join a class action lawsuit if I was affected by Uloric?

Yes, individuals affected by Uloric may join a class action lawsuit if one is available. Class action lawsuits allow multiple plaintiffs to combine their cases.

Get a Free Uloric Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for Uloric-related injuries. Statutes of limitations restrict how long you have to file a claim after your injury.

The Product Liability Litigation Group at Schmidt & Clark, LLP offers:

• Free, confidential consultations
• No upfront costs or fees
• Payment only if we win your case

References

1. https://mdnewsline.com/fda-marks-takedas-uloric-as-discontinued-in-the-u-s/
2. https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-increased-risk-death-gout-medicine-uloric-febuxostat
3. https://www.classactionlawsuithelp.com/uloric_and_arf/%22
4. https://www.consumersafety.org/drug-lawsuits/uloric/
5. https://www.uspharmacist.com/article/how-patients-on-febuxostat-for-gout-should-be-cautioned