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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.
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:
- $9 billion verdict in Actos trial.*
- $2.5 billion in DePuy Hip settlement.
- $13.5 million verdict in Vioxx trial.
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. (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.
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.