Xeljanz Lawsuit

The FDA has confirmed that rheumatoid arthritis medication Xeljanz may increase the risk of life-threatening heart attack, stroke, blood clots, or cancer. Some people have filed lawsuits against Pfizer for serious injuries caused by Xeljanz.

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The U.S. Food and Drug Administration (FDA) has issued another warning about auto-immune drug Xeljanz (tofacitinib) and Xeljanz XR. The new warning indicates that preliminary results from a safety study show that Xeljanz may increase the risk for cardiovascular events and cancer, even when taken at the lower dose of 5 mg twice daily.

Previously, the medication had been linked to an increased risk of venous thromboembolic event (VTE) or blood clot formation in the veins when used in RA patients at the dose of 10 mg twice daily. This may include episodes such as deep vein thrombosis (DVT) in the legs or pulmonary embolism (PE) lungs, either of which may be serious or life-threatening. Patients taking only Xeljanz 5 mg twice daily showed an increased risk of death as well. Other serious concerns about the medication have included serious infections, cancer, and sudden cardiac death.

People who took Xeljanz and were injured or died—as well as their loved ones—may be filing lawsuits against drug manufacturer, Pfizer. Complications from Xeljanz may include:

  • Heart attack
  • Stroke (ischemic)
  • Blood clots, including pulmonary embolism, deep vein thrombosis, and arterial thrombosis
  • Breast cancer
  • Lung cancer
  • Pancreatic cancer
  • Prostate cancer
  • Melanoma
  • Death (sudden cardiac death or due to one of the above injuries)

In its prior warnings, the FDA required that labelling on Xeljanz and Xeljanz XR be updated. It also placed restrictions on the dosing of the medication. While the results from the latest study are preliminary, the FDA may issue new warnings or restrictions on prescribing.

Xeljanz Post-Marketing Studies

Xeljanz (tolfacitinib) is a member of a class of medications known as Janus kinase (JAK) inhibitors, which work to treat immune disease by decreasing immune system activity or response. It is approved to treat autoimmune disorders including Rheumatoid Arthritis (RA), Psoriatic Arthritis (PSAPSA), and Ulcerative Colitis (UC). After its 2012 approval, Pfizer was required to undertake post-marketing safety studies to examine further risks of Xeljanz.

In February 2019, results of the first safety trial showed that Xeljanz may increase the risk of blood clotting events known as venous thromboembolic (VTE) events such as deep vein thrombosis (DVT) and pulmonary embolism (PE), which may be serious or life-threatening.

The study had examined RA patients over the age of 50 who had at least one cardiovascular risk factor, such as high blood pressure. The study compared patients taking tofacitinib 10mg twice daily, tofacitinib 5mg twice daily, and a control group of TNF inhibitors such as Humira.

After initial study results indicated increased clotting risk in higher dosing patients, these high dose users were transferred to lower dose protocol and subsequent results showed that increased risk of death may occur at lower dose as well.

In February 2021, the FDA issued a new safety alert warning that the latest preliminary results from the clinical safety trial showed an increased risk of serious heart-related events and cancer in patients who took Xeljanz or Xeljanz XR.

The increased risk for Xeljanz patients occurred at both the higher 10 mg twice daily and lower 5 mg twice daily dosing used for RA, PsA and UC when compared to another type of medication used for autoimmune disorders, the tumor necrosis factor (TNF) inhibitors. Prior warnings only included the higher dose.

FDA Black Box Warning

Based on the initial blood clot warnings for larger 10 mg dosing, in July 2019 the FDA required that black box warning information be added to prescribing information. A black box warning is the most serious warning that can be issued by the FDA and requires that information be printed at the top of prescribing information enclosed in a black box.

The current black box statement for Xeljanz and Xeljanz XR includes warnings for:

  • Serious infections including active tuberculosis, invasive fungal infections, opportunistic pathogens including herpes zoster and other viruses or bacteria, along with tuberculosis.
  • Increased risk of death in patients with cardiovascular risk factor.
  • Lymphoma and other types of cancer.
  • Blood clots including pulmonary embolism, deep vein thrombosis and arterial thrombosis.

As part of the added black box warning in July 2019, the FDA also stated that Xeljanz 10 mg twice daily was only approved for use in Ulcerative colitis but not for rheumatoid arthritis or other conditions. The agency also restricted use of Xeljanz in ulcerative colitis to patients who could not take or had not responded to other medications and stated that UC patient should be given the lowest dose possible, for the shortest duration required.

The newest results are still considered to be preliminary, but the FDA may take further action or put in place further restrictions based on an increased risk of cardiovascular events and cancer at the lower dose of Xeljanz 5 mg twice daily.

Xeljanz Side Effects

Most medication side effects may be mild to moderate and will go away with time. Others may be more severe, serious, or even life-threatening. The newest Xeljanz information, in addition to older warnings indicate that Xeljanz serious side effects may include:

  • Heart attack
  • Stroke (ischemic)
  • Blood clots, including pulmonary embolism, deep vein thrombosis, and arterial thrombosis
  • Breast cancer
  • Lung cancer
  • Pancreatic cancer
  • Prostate cancer
  • Melanoma
  • Death (sudden cardiac death or due to one of the above injuries)

Symptoms that warrant immediate treatment include:

  • Swelling, pain, warmth or redness in lower leg
  • Shortness of breath
  • Chest or back pain
  • Sweating
  • Coughing up blood
  • Clammy skin
  • Pale, gray or bluish-colored appearance
  • Changes in consciousness
  • Difficulty speaking
  • One-sided numbness or weakness
  • Symptoms of cancer

Serious side effects may sometimes occur without warning or symptoms but may lead to sudden death in severe cases and should be treated as a medical emergency.

Other Xeljanz side effects may include:

  • Stomach or intestinal perforations
  • Serious infections
  • Liver enzyme elevation
  • Laboratory abnormalities
  • Lymphoma
  • Non-melanoma skin cancer
  • Other types of cancer
  • Allergic or hypersensitivity reactions

Bothersome or persistent side effects should be reported to a healthcare professional. All sudden or severe symptoms should be treated as a medical emergency.

Xeljanz Lawsuit Claims

People who took Xeljanz for RA, PsA, or UC and suffered injury may be eligible for compensation through a Xeljanz lawsuit. Injuries which may have been caused by Xeljanz include:

  • Heart attack
  • Ischemic stroke
  • Deep vein thrombosis (DVT)
  • Pulmonary embolism (PE)
  • Death due to DVT or PE
  • Breast cancer
  • Lung cancer
  • Pancreatic cancer
  • Prostate cancer
  • Melanoma
  • Death (sudden cardiac death or due to one of the above injuries)

Past medical injury lawsuits have provided compensation for:

  • Medical costs
  • Lost wages
  • Pain and suffering
  • Future medical costs
  • Wrongful death
  • Other damages

People or loved ones of those who have been injured after taking Xeljanz should seek legal assistance.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.




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