A Xeljanz lawsuit will likely argue that Pfizer, the drug’s maker, failed to warn patients that Xeljanz raises the risk of potentially fatal blood clots. A recent clinical trial found Xeljanz and Xeljanz XR (or tofacitinib) – used to treat rheumatoid or psoriatic arthritis and colitis – may increase the risk of dangerous and potentially fatal blood clots in the lungs. Xeljanz may increase the risk of thromboembolic events such as pulmonary embolism (PE) or deep vein thrombosis (DVT). Xeljanz may also increase overall mortality risk.
DVT, PE Injuries – A Failure to Warn
DVTs and PEs can be dangerous and even fatal. The current labels for these medications (as of June 5, 2019) fail to warn of this risk.
What Is Xeljanz?
Xeljanz and Xeljanz XR (tofacitinib) are made by Pfizer. The drugs were FDA approved to treat adults with rheumatoid arthritis (RA), psoriatic arthritis (PSA), or ulcerative colitis (UC). Xeljanz and Xeljanz XR belong to a class of drugs called Janus kinase (JAK) inhibitors; these drugs are alleged to decrease activity in the immune system. They are taken orally in tablet form.
Our law firm is investigating lawsuits for people 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, typically the legs) after taking Xeljanz or Xeljanz XR for rheumatoid or psoriatic arthritis or colitis.
Free Legal Consultation
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, contact us now for a free confidential consultation.
Matthews & Associates’ attorneys have worked for decades in dangerous drugs litigation, as well as in medical device cases. We may be able to help you seek compensation for injuries that include medical expenses, lost wages, pain and suffering.
Xeljanz Study suggests increased risk of Blood Clots, Death
An ongoing post-marketing safety study of tofacitinib has found a statistically significant and “clinically important” higher rate of pulmonary embolism (PE) for rheumatoid arthritis patients who take 10 mg of Xeljanz twice a day compared to a control group given tumor necrosis factor inhibitors (TNFis). The study has also found an increased risk of death compared to patients who take just 5 mg of Zeljanz twice a day compared with the control group.
The U.S. FDA required this safety study to be conducted in 2012 when the agency first approved of Xeljanz. The study involves rheumatoid arthritis patients over 50 with at least one cardiovascular risk factor. It contains two dose arms of tofacitinib and a control group given TNFis.
After the study’s Data Safety Monitoring Board found increased risk in study participants taking the higher dose, the DSMB said it would move those patients to the lower dose; that change was announced by Xeljanz’ maker Pfizer on February 19, 2019.
FDA Safety Announcement re: Xeljanz
On February 25, 2019, an FDA safety announcement revealed that the postmarket clinical trial showed an increased risk of blood clots in the lungs and an increased death rate in rheumatoid arthritis patients taking the 10 mg twice daily dose of Xeljanz or Xeljanz. The FDA said it was “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.”
Today (as of June 4, 2019), only the 5 mg once or twice daily dose of Xeljanz or Xeljanz XR is approved for rheumatoid arthritis. 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.
FDA Adverse Event Data re: Xeljanz Patients
As of late March 2019, according to the FDA Adverse Event Reporting System (FAERS), 109 cases of PE, including 14 cases resulting in death, have been reported to the FDA since 2010. Sixty three (63) cases of DVT, including five related deaths, have been reported in those taking tofacitinib, Xeljanz, or Xeljanz XR.
It’s important to remember that adverse events frequently go unreported, especially when there is no publicized connection between a drug and a specific adverse event. Most experts estimate that just 1-10% of actual adverse events are reported to the FDA, though the FAERS system may also contain some duplicates.
Xeljanz Side Effects
Xeljanz side effects listed on its label include:
- 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:
- Sudden trouble breathing.
- Shortness of breath.
- Chest pain (or back pain).
- Coughing up blood.
- Severe sweating.
- Skin that is clammy or bluish-colored.
- Swelling in the affected leg.
- Pain in your leg (often feeling like a cramp).
- Discolored skin on the leg.
- Warmth in the area affected.
Free Legal Consultation
If you or someone you love suffered injury after taking Xeljanz (tofacitinib), click this link now to contact us by email, or call us at (888) 520-5202. We offer a no obligation, free legal consultation. You will have no out-of-pocket expenses with us. We don’t get paid unless we can take your case and win it in court or settle it.