Xeljanz May Increase Risk of Death, PE

A recent clinical trial has found that tofacitinib, the nonproprietary name for Xeljanz and Xeljanz XR — drugs indicated for rheumatoid or psoriatic arthritis and colitis — may increase the risk of dangerous and potentially fatal blood clots in the lungs, and increase the risk of mortality overall. (1)
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What Is Xeljanz?

Xeljanz and Xeljanz XR (tofacitinib) are medications manufactured by Pfizer and approved for treatment of adults with the following conditions:

  • Rheumatoid arthritis (RA).
  • Psoriatic arthritis (PSA).
  • Ulcerative colitis (UC).

Xeljanz and Xeljanz XR belong to a class of drugs called Janus kinase (JAK) inhibitors, which can decrease activity in the immune system. (2) Xeljanz and Xeljanz XR are tablets taken orally.

Lawsuit Allegations

We are now accepting lawsuits on behalf of patients who experienced a venous thromboembolic event (VTE) such as a PE (a blood clot in the lungs) or a DVT (a blood clot in the deep veins of the body, usually the legs) after taking Xeljanz or Xeljanz XR for rheumatoid or psoriatic arthritis, or for colitis.

Did you suffer from a blood clot after taking Xeljanz or Xeljanz XR? Contact us now for a free evaluation.

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DVTs and PEs can be dangerous, and even fatal. The labels for these medications do not presently warn of this risk. (3)

If you or a loved one suffered from a blood clot after taking any dose of Xeljanz or Xeljanz XR for ulcerative colitis, rheumatoid arthritis, or psoriatic arthritis, please reach out today for a free consultation.

We can help you explore your legal options. You may be able to seek compensation for your injuries, including medical expenses, lost wages, and pain and suffering.

Our law firm, Weitz & Luxenberg, has a Drug and Medical Device Litigation Practice Group with attorneys who have decades of experience in complex pharmaceutical litigation.

We have successfully represented thousands of victims harmed by defective drugs and have helped secure billions of dollars of compensation for our clients, including:

Recent Xeljanz Study Suggests Increased Risk of Blood Clots and Death

Xeljanz 5mg

An ongoing post-marketing safety study of tofacitinib found a statistically significant and “clinically important” higher rate of pulmonary embolism (PE) for rheumatoid arthritis patients taking a 10 mg twice daily dose of Xeljanz compared to a control group given tumor necrosis factor inhibitors (TNFis). There was also an increased risk of death compared to patients in the 5 mg twice daily dose and the control group. (4) (5)

The U.S. Food and Drug Administration (FDA) required this safety study be conducted when it initially approved Xeljanz in 2012. The study is of rheumatoid arthritis patients over the age of 50 with at least one cardiovascular risk factor. It contains two dose arms of tofacitinib and a control group given TNFis. (6)

After finding increased risk in study participants taking the higher dose, the study’s Data Safety Monitoring Board (DSMB) said it would move those patients to the lower dose, announced by drug manufacturer Pfizer on February 19, 2019. (7)

A few days later, on February 25, 2019, the FDA released a safety announcement about the increased risk of blood clots in the lungs and death in rheumatoid arthritis patients taking the 10 mg twice daily dose of Xeljanz or Xeljanz XR in the postmarketing clinical trial. The FDA stated it is “working with the manufacturer to evaluate other currently available safety information for tofacitinib and will update the public with any new information based on…ongoing review.” (8)

Currently, only the 5 mg once or twice daily dose of Xeljanz or Xeljanz XR is approved for rheumatoid arthritis, but a 10 mg twice daily dose is approved for ulcerative colitis. The FDA urges patients to not stop or change their dose of Xeljanz or Xeljanz XR without first consulting with their physician, as doing so could worsen their condition. (9)

Potential Lawsuit Claims

We are currently exploring potential lawsuit claims on behalf of adults with rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis who took Xeljanz or Xeljanz XR and experienced any of the following:

  • Deep vein thrombosis (DVT).
  • Pulmonary embolism (PE).
  • Death due to DVT or PE.

FDA Adverse Event Data on Xeljanz Patients

As of the end of March, 2019, according to the FDA Adverse Event Reporting System (FAERS), there have been 109 cases of PE, including 14 cases resulting in death, reported to the FDA since 2010. There have been 63 cases of DVT, including five cases resulting in death, in those taking tofacitinib, Xeljanz, or Xeljanz XR. (10)

Adverse events frequently go unreported, especially when there is no publicized connection between a drug and a specific adverse event. The FAERS system may also contain duplicate reports.

Holding thigh deep vein thrombosis

Serious Side Effects of Xeljanz

The Xeljanz label warns of many serious side effects, including:

  • Perforations of the stomach or intestines.
  • Serious infections.
  • Lymphoma, other cancers.
  • Liver enzyme elevations and other laboratory abnormalities.
  • Non-melanoma skin cancers.
  • Hypersensitivity reactions.

The current Xeljanz and Xeljanz XR labels do not warn of venous thromboembolic events, although a recent postmarketing trial found an increased risk of PE in certain patients taking a 10 mg twice daily dose of Xeljanz.

Signs of venous thromboembolic events such as PE or deep vein thrombosis (DVT) may include:

Symptoms of PE:

  • Sudden trouble breathing.
  • Shortness of breath.
  • Chest pain (or back pain).
  • Coughing up blood.
  • Severe sweating.
  • Skin that is clammy or bluish-colored.
  • No symptoms. (11) (12)

Symptoms of DVT:

  • Swelling in the affected leg.
  • Pain in your leg (often feeling like a cramp).
  • Discolored skin on the leg.
  • Warmth in the area affected.
  • No symptoms. (13)

Patients experiencing these symptoms should seek medical attention immediately. Consult your doctor before stopping any prescribed medication.

*Past performance is no guarantee of future results. The Actos verdict was reduced to approximately $38 million by the trial court on October 27, 2014. The settlements in which Weitz & Luxenberg played leadership roles included patients not represented by W&L.

  1. U.S. Food & Drug Administration. (2019, February 25). Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm631871.htm
  2. Prescribing Information. (2018, October). XELJANZ® (tofacitinib) tablets, for oral use. XELJANZ®XR (tofacitinib) extended-release tablets, for oral use. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s020,208246s006lbl.pdf
  3. Ibid.
  4. Pfizer. (2019, February 19). Pfizer Announces Modification to Ongoing Tofacitinib FDA Post-Marketing Requirement Study in Patients with Rheumatoid Arthritis. Retrieved from https://investors.pfizer.com/investor-news/press-release-details/2019/Pfizer-Announces-Modification-to-Ongoing-Tofacitnib-FDA-Post-Marketing-Requirement-Study-in-Patients-with-Rheumatoid-Arthritis/default.aspx
  5. ClinicalTrials.gov. (2019, March 15). Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis. Retrieved from https://clinicaltrials.gov/ct2/show/NCT02092467?term=A3921133&rank=1
  6. U.S. Food & Drug Administration. (2019, February 25). Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm631871.htm
  7. Pfizer. (2019, February 19). Pfizer Announces Modification to Ongoing Tofacitinib FDA Post-Marketing Requirement Study in Patients with Rheumatoid Arthritis. Retrieved from https://investors.pfizer.com/investor-news/press-release-details/2019/Pfizer-Announces-Modification-to-Ongoing-Tofacitnib-FDA-Post-Marketing-Requirement-Study-in-Patients-with-Rheumatoid-Arthritis/default.aspx
  8. U.S. Food & Drug Administration. (2019, February 25). Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm631871.htm
  9. Ibid.
  10. U.S. Food & Drug Administration. (2018, December 31). FDA Adverse Event Reporting System: Xeljanz and Xeljanz XR. Retrieved from https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/8eef7d83-7945-4091-b349-e5c41ed49f99/state/analysis
  11. U.S. Food & Drug Administration. (2019, February 25). Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm631871.htm
  12. MedlinePlus. (2018, August 10).Pulmonary Embolism. Retrieved from https://medlineplus.gov/pulmonaryembolism.html
  13. Mayo Clinic. (2018, March 6). Deep vein thrombosis (DVT). Retrieved from https://www.mayoclinic.org/diseases-conditions/deep-vein-thrombosis/symptoms-causes/syc-20352557

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