Xeljanz Lawsuit | 2025 Latest Updates

FDA Reports and Statistics

A post-marketing safety study (A3921133), required by the FDA and completed in January 2021, revealed that Xeljanz (tofacitinib) patients taking 10 mg twice daily had an increased risk of pulmonary embolism (PE) and all-cause mortality compared to those taking 5 mg twice daily or tumor necrosis factor inhibitors (TNFi). In February 2019, the study’s Data Safety Monitoring Board (DSMB) identified a ‘statistically and clinically important difference’ in rates of PE (19 vs. 3 cases) and mortality (45 vs. 25 deaths) for 10 mg twice daily vs. TNFi, prompting a dose reduction. Final results (2021) also showed elevated lung cancer risk across both doses (4.19% malignancy vs. 2.89% TNFi), with PE at 0.54 (10 mg), 0.27 (5 mg), and 0.09 (TNFi) per 100 person-years, and mortality at 0.89 (10 mg), 0.70 (5 mg), and 0.47 (TNFi). Despite deep vein thrombosis (DVT) and PE reports in the FDA Adverse Event Reporting System (FAERS) from 2013-2018, Pfizer stated in February 2019 that prior safety trials showed no similar signals to A3921133’s interim findings. As of March 17, 2025, Xeljanz lawsuits against Pfizer continue, alleging blood clots, CV events, and cancer, with over 132,000 FAERS reports by 2024, but no major settlements are confirmed.

Xeljanz Injuries & Side Effects

Xeljanz use has been linked to numerous serious and potentially life-threatening side effects across varying levels of severity.

• Critical: Death, blood clots (deep vein thrombosis, pulmonary embolism), cancer (lymphoma, non-melanoma skin cancer)
• Severe: Serious infections (extrapulmonary tuberculosis, invasive fungal infections), organ damage
• Moderate: Jaundice (yellowing of the eyes and/or skin), skin rash
• Common: Nausea, headaches, vomiting

Blood Clot Symptoms

Signs of a pulmonary embolism may include:

• Sudden shortness of breath or difficulty breathing
• Chest pain or pain in your back
• Coughing up blood
• Excessive sweating
• Clammy or bluish-colored skin

Do You Qualify for a Xeljanz Lawsuit?

You may qualify for a Xeljanz lawsuit if:

• You used Xeljanz or Xeljanz XR between 2013 and the present
• You experienced serious side effects including blood clots, pulmonary embolism, heart attack, stroke, cancer, or serious infections
• The injuries required medical treatment or hospitalization
• You can provide medical documentation linking your injuries to Xeljanz

Check out the other similar dangerous drugs lawsuits we’ve taken on.

Evidence Required for a Xeljanz Lawsuit

To build a strong case, you’ll need to gather:

• Prescription Records: Documentation proving Xeljanz was prescribed for your condition
• Medical Records: Complete medical history, treatment records, and laboratory results showing your diagnosis and complications
• Adverse Event Documentation: Reports documenting side effects linked to Xeljanz
• Physician Statements: Written opinions from healthcare providers linking your complications to Xeljanz

Damages You Can Recover

A successful Xeljanz lawsuit could help you recover compensation for:

• Medical expenses, past and future
• Lost wages and reduced ability to earn an income
• Pain and suffering
• Funeral expenses (in wrongful death cases)
• Loss of consortium and companionship
• Lost financial security

If the case goes to trial, the judge may imposepunitive damages as well.

Xeljanz Recall Information

As of March 17, 2025, there has been no complete FDA recall of Xeljanz (tofacitinib), but the agency has taken significant actions:

• February 25, 2019: Issued a safety alert noting an increased risk of pulmonary embolism (PE) and death with the 10 mg twice-daily dose, based on interim A3921133 study data, compared to 5 mg twice daily or TNFi.
• July 26, 2019: Approved a Boxed Warning for the 10 mg twice-daily dose due to elevated risks of PE, deep vein thrombosis (DVT), and death, restricting its use in ulcerative colitis to patients failing TNFi.
• February 4, 2021: Expanded warnings after final A3921133 results showed increased risks of major adverse cardiovascular events (MACE), cancer, and continued PE concerns at both 5 mg and 10 mg twice-daily doses vs. TNFi.
• On September 1, 2021, the FDA updated Boxed Warnings across JAK inhibitors, including Xeljanz, to reflect these risks and limited approved uses to patients not responding to TNFi. No market withdrawal has occurred, though lawsuits persist over these safety issues.

Statute of Limitations for Xeljanz Lawsuits

Time is limited to file a Xeljanz lawsuit. While specific timeframes vary by state, most personal injury claims must be filed within 2-3 years from the date you discovered or should have discovered your injury was related to Xeljanz. Failing to file within your state’s statute of limitations will likely result in losing your right to seek compensation.

FAQs

1. What is Xeljanz?

Xeljanz (tofacitinib) is a prescription drug used to treat rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis. It works by inhibiting a signaling pathway known as the “JAK pathway” that causes inflammation.

2. What’s the difference between Xeljanz and Xeljanz XR?

Xeljanz comes in 5 mg or 10 mg tablets taken twice daily, while Xeljanz XR is an 11 mg extended-release tablet taken once daily. Both can be taken with or without food.

3. What are the legal grounds for a Xeljanz lawsuit?

Lawsuits claim that Pfizer defectively designed the drug, there may have been manufacturing defects, and most significantly, that Pfizer failed to adequately warn of the heart attack risks and other serious side effects.

4. Have there been any Xeljanz lawsuit settlements?

To date, there have been no large settlements involving Xeljanz and blood clots or pulmonary embolisms. This litigation is recent and will likely take years to resolve.

5. Should I stop taking Xeljanz if I’m concerned about side effects?

The FDA cautions patients not to stop taking Xeljanz without talking to their doctor first, as doing so could also result in adverse effects.

6. How do I know if I’m experiencing side effects from Xeljanz?

Monitor for symptoms such as shortness of breath, chest pain, swelling in limbs, fever, persistent cough, or unusual bruising. Contact your doctor immediately if you experience these symptoms.

7. What compensation could I receive for a wrongful death claim?

Compensation for wrongful death claim can include funeral expenses, loss of consortium and companionship, and lost financial security.

8. How much does it cost to hire a lawyer for a Xeljanz lawsuit?

Schmidt & Clark, LLP works on a contingency fee basis, meaning there are no upfront costs and you only pay if they win your case.

9. How long will a Xeljanz lawsuit take?

The timeline varies, but pharmaceutical litigation typically takes several years to resolve, especially when cases are consolidated into Multi-District Litigation (MDL).

10. What should I do if I think I have a case?

Contact Schmidt & Clark, LLP for a free, confidential case evaluation to determine if you qualify for a Xeljanz lawsuit.Related Article: Pfizer Drugs Recall Lawsuit

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action against Pfizer for Xeljanz-related injuries. Most states have statutes of limitations that restrict how long you have to file a claim after an injury occurs.Schmidt & Clark, LLP offers:

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

Don’t delay seeking the compensation you deserve for injuries caused by Xeljanz. Our experienced pharmaceutical litigation team is ready to review your case and fight for justice on your behalf.[START YOUR FREE CASE REVIEW NOW]References: [1] https://www.drugwatch.com/xeljanz/lawsuits/ [2] https://www.millerandzois.com/products-liability/drugs/xeljanz-lawsuits/