Xeljanz Lawsuit

In February of 2021, the U.S. Food & Drug Administration alerted the public that clinical safety trials have linked the medication Xeljanz to an increased risk of blood clots, heart problems, and cancer. If you have taken Xeljanz/Xeljanz XR and were diagnosed with any of these injuries, contact us for a free case evaluation.

About Xeljanz, Xeljanz XR

Xeljanz and Xeljanz XR (tofacitinib) are prescription medications used to treat adults with the following conditions:

  • rheumatoid arthritis
  • psoriatic arthritis
  • ulcerative colitis (1)

An overactive immune system contributes to rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Tofacitinib (Xeljanz, Xeljanz XR) works by decreasing the activity of the immune system. (1)

Xeljanz and Xeljanz XR are manufactured by Pfizer Inc., an American multinational pharmaceutical corporation.

Xeljanz and Xeljanz XR Complications

On July 26, 2019, The U.S. Food and Drug Administration (FDA) approved new warnings about an increased risk of blood clots and death with a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR), prescribed for patients with ulcerative colitis. (1)

The January 2019 results of an ongoing clinical safety trial found the following:

  • A higher rate of blood clots in the lung in rheumatoid arthritis patients who received tofacitinib at 10 mg twice daily, compared to patients who received tumor necrosis inhibitor (TNF) blockers
  • A greater number of deaths from all causes in rheumatoid arthritis patients who received tofacitinib at 10 mg twice daily, compared to patients who received TNF blockers. (1)

The FDA required this safety study as part of the approval process for Xeljanz in 2012. 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. (1)

blood clot

Blood Clot Warning Signs & Symptoms:

  • Sudden shortness of breath
  • Chest pain that worsens with breathing
  • Swelling of a leg or arm
  • Leg pain or tenderness, or red or discolored skin in the painful or swollen leg or arm (1)

Blood clots can form in, or travel to, the blood vessels in the brain, heart, kidneys, lungs, and limbs. A clot in the veins deep in the limbs is called deep vein thrombosis, which often occurs in the deep veins of the legs. If a blood clot in a deep vein breaks off, moves through the bloodstream to the lungs, and blocks blood flow, it is called a pulmonary embolism. Other complications of blood clots include strokeheart attackkidney problems or failure, and pregnancy-related complications. (2)

Pulmonary Embolism Warning Signs & Symptoms:

  • 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 (4) (5)

Deep Vein Thrombosis Warning Signs & Symptoms:

  • 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 (6)

DVTs and PEs can be dangerous or even fatal. The labels for Xeljanz and Xeljanz XR did not warn of this risk prior to the FDA-approved boxed warning. (1)(3)

Xeljanz and Cancer:

Taking Xeljanz has been found to increase the risk of developing cancer. Xeljanz impacts JAK enzymes, which affect the growth and spread of cells. Consequently, Xeljanz has not been strictly associated with just one type of cancer, but rather a variety of different cancers.

Prior to the February 2021 FDA safety communication, a pair of medical studies analyzed the (then-interim) results of 19 Xeljanz clinical trials. Both studies examined how many subjects taking Xeljanz had developed cancer, including non-melanoma skin cancer. Both found that the number of people who took Xeljanz faced an increased risk of cancer.

Xeljanz, Xeljanz XR Lawsuit | Get Help Now

Martin, Harding & Mazzotti, LLP is currently accepting cases on behalf of patients who took tofacitinib (Xeljanz, Xeljanz XR) for rheumatoid or psoriatic arthritis, or for colitis and experienced complications such as:

  • Blood clots including:
    • Pulmonary embolism (PE)
    • Deep vein thrombosis (DVT)
    • Ischemic stroke
    • Cerebrovascular accident
    • Transient ischemic attack
    • Pulmonary thrombosis
    • Arterial thrombosis
    • Death due to PE or DVT
  • Cancers most frequently associated with Xeljanz include:
    • Breast cancer
    • Colon cancer
    • Lung cancer
    • Non-Hodgkin’s lymphoma
    • Prostate cancer
  • Serious cardiovascular events such as:
    • Cardiac arrest
    • Cardiovascular death
    • Congestive heart failure
    • Coronary revascularization
    • Myocardial infarction

If you or a loved one are suffering from complications after taking Xeljanz or Xeljanz XR, you may be entitled to compensation. Our experienced defective drug and medical device attorneys can help. Click, Chat or call 1(800) 529-1010 24/7 for a free case evaluation.

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  1. U.S. Food & Drug Administration (2019, July 26) FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-boxed-warning-about-increased-risk-blood-clots-and-death-higher-dose-arthritis-and
  2. MedlinePlus. (2019, April 25) Blood Clots. Retrieved from https://medlineplus.gov/bloodclots.html
  3. 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
  4. 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
  5. MedlinePlus. (2019, May 14) Pulmonary Embolism. Retrieved from https://medlineplus.gov/pulmonaryembolism.html
  6. Mayo Clinic. (2018, March 6) Deep vein thrombosis (DVT). Retrieved from https://www.mayoclinic.org/diseases-conditions/deep-vein-thrombosis/symptoms-causes/syc-20352557
  7. U.S. Food & Drug Administration. (2021, February 4). Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib). Retrieved from Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) | FDA
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