Xeljanz Side Effect Injuries

We are investigating cases against Pfizer regarding the pharmaceutical drug Xeljanz for thrombotic injuries, including but not limited to blood clots in the lungs (pulmonary embolism, PE), blood clots in veins of the legs (deep vein thrombosis, DVT) , and/or blood clots in arteries (arterial thrombosis). This most often occurs when Xeljanz as prescribed at the 10 mg level or higher, but can also occur when prescribed even as low as at the 5 mg-level. We are particularly interested in persons who were prescribed Xeljanz for any approved purpose, including rheumatoid arthritis and ulcerative colitis.

The FDA published a new drug safety advisory for Xeljanz in early September 2021. That advisory states that any dosage amount of Xeljanz creates “a higher rate of serious heart-related events such as heart attack and stroke, cancer, blood clots, and death in patients treated with both doses of Xeljanz compared to those treated with TNF blockers [such as Enbrel (etanercept) and Humira (adalimumab)]”.

Most recently, on December 2, 2021, FDA added its strongest “black box” warning to Xeljanz. In an unprecedented move, FDA’s added warnings explicitly state that prescribers are highly suggested to use TNF blockers instead of Xeljanz for treatment of ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis. In fact, the FDA’s black box warnings goes so far to state that JAK inhibitors, including Xeljanz, have a “[h]igher rate of all-cause mortality, including sudden cardiovascular death with Xeljanz vs. TNF blockers [such as Enbrel (etanercept) and Humira (adalimumab)]”. You can read the new warning here.

Xeljanz may increase risk of death, pulmonary embolism and other heart/thrombotic events, and cancer

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

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. Xeljanz and Xeljanz XR are tablets taken orally.

Xeljanz Injury Lawsuit Allegations

We are now accepting potential claims on behalf of patients who experienced the following after taking Xeljanz or Xeljanz XR for rheumatoid or psoriatic arthritis, or for ulcerative colitis:

  • venous thromboembolic event (VTE) such as a pulmonary embolism, also known as a “PE” (a blood clot in the lungs) or deep vein thrombosis, also known as a “DVT” (a blood clot in the deep veins of the body, usually the legs)
  • any form of cancer (with the exception of skin cancer)

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

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

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

Did you suffer from a blood clot after taking Xeljanz or Xeljanz XR?

DVTs and PEs can be dangerous, and even fatal.

The labels for these medications do not presently warn of this risk.

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.

Recent Xeljanz Study Suggests Increased Risk of Blood Clots and Death

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.

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.

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.

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.”

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.

Contact us

Please contact us using the form below or by calling us at 1 800 541-7358. We will help affected persons and families gather the information and file the claims needed to seek recompense for any injuries, suffering, or related harm. We will review your Xeljanz injury claim for free, confidentially, and with no obligation on your part.

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    injury legal team

    Lieff Cabraser mass tort and injury practice partners Sarah R. London, Wendy R. Fleishman, and Mark P. Chalos.


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