Xeljanz Lawsuit

Xeljanz (tofacitinib) and Xeljanz XR is a prescription medication used to treat autoimmune disorders such as rheumatoid arthritis (RA) and Ulcerative Colitis (UC). The FDA has issued a new safety alert indicating that Xeljanz may increase the risk for cardiovascular events and cancer. This is in addition to prior warnings of increased risk of serious blood clot-related events like pulmonary embolism and increased risk of death. Some people are filing Xeljanz lawsuits against drug company Pfizer, for injuries caused by the medication.

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  • Xeljanz Overview
  • FDA Side Effect Warnings
  • Xeljanz Black Box Warning
  • Xeljanz Rheumatoid Arthritis Treatment
  • Xeljanz Blood Clot Risk
  • Venous Thromboembolic Events
  • Pulmonary Embolism
  • Other Xeljanz Side Effects
  • Xeljanz Lawsuit Claims

Xeljanz Overview

Xeljanz is the brand name of the prescription medication, tofacitinib which is manufactured by Pfizer. It is approved to treat autoimmune disorders including Rheumatoid Arthritis (RA), Psoriatic Arthritis (PSA) and Ulcerative Colitis (UC) and is also used for other rheumatic or immune conditions. Xeljanz is also available in a sustained release form, Xeljanz XR.

Xeljanz and Xeljanz XR are prescribed to thousands of patients every year and are responsible for about $1.7 billion in annual revenue for Pfizer. Despite the successful treatment of autoimmune disease for many patients, it has been shown to increase the risk of death in some patients due to venous thromboembolic events (VTE).  The U.S. Food and Drug Administration has said that hundreds of serious adverse event reports have been filed for blood clotting events including pulmonary embolism (PE) and deep vein thrombosis (DVT), some of which have resulted in death.

In February of 2021, the FDA issued a new safety alert which indicates that Xeljanz may increase the risk for life-threatening cardiovascular events and cancer, even when taken at the lower 5 mg twice daily dose.

This comes two years after the Agency had issued a prior warning regarding an increased risk of thromboembolic events such as deep vein thrombosis (DVT) which may lead to pulmonary embolism (PE), heart attack, stroke, and death. The blood clot risk was seen in the higher dosing range of 10 mg twice daily, but lower doses also showed a risk of all-cause death.

Prior warnings have resulted in changes to drug labeling with the addition of black box information and added restrictions to prescribing of Xeljanz. The FDA has stated that the new results are preliminary, but they will be working with the manufacturer to evaluate additional information. Some experts suggest that new warnings and prescribing restrictions may be expected.

People may be considering filing Xeljanz drug injury lawsuits against Pfizer for injuries caused by the medication. Lawsuits may include people or loved ones of those who took Xeljanz and experienced:

  • Heart attack
  • Stroke (ischemic)
  • Blood clots
    • pulmonary embolism
    • deep vein thrombosis
    • arterial thrombosis
  • Breast cancer
  • Lung cancer
  • Pancreatic cancer
  • Prostate cancer
  • Melanoma
  • Death

FDA Side Effect Warnings

In addition to VTE events such as PE or DVT, the newest warning indicates Xeljanz may increase the risk for cardiovascular events and cancer, even when taken at lower doses.

Other serious warnings include:

Serious infections including viral, bacterial and fungal infections

  • Lymphoma or other cancer
  • Tuberculosis
  • Reactivation of Herpes or Hepatitis virus
  • Gastrointestinal perforation
  • Hypersensitivity or allergic reaction

Side effects which are sudden or severe should be reported to a health care provider right away.

Xeljanz Black Box Warning

Xeljanz prescribing information includes several black box warnings. Black box statements are the most serious type of warning that can be issued by the FDA and are printed at the top of prescribing information enclosed in a black box.

Xeljanz black box warning includes information about:

  • Infection risk
  • Increased risk of death in patients with cardiovascular risk factor.
  • Lymphoma and other cancers
  • Blood clots

After the February 2019 warning, the FDA added information to Xeljanz boxed statement and imposed new restrictions on prescribing for Xeljanz. Though the Agency has not made changes based on the newest, preliminary safety results, changes to Xeljanz labelling may be forthcoming from the FDA.

Xeljanz Rheumatoid Arthritis Treatment

Rheumatoid arthritis and other autoimmune disorders occur when an overactive immune system begins to attack certain tissues of the body such as the joints, skin, or gastrointestinal lining. This can lead to inflammation, pain and damage in the affected area and result in diseases such as RA (joints), PSA (skin and joints) and UC (gastrointestinal system).

Xeljanz works by blocking the Janus Kinase (JAK) group of enzymes which contribute to inflammation. Blocking this enzyme can help to reduce the immune response and decrease inflammation. In addition to approved use in RA, PSA and UC, Xeljanz has been used off-label for other immune-related disorders.

Though Xeljanz was approved for use in the U.S. in 2012, its use in the EU has been denied over concerns of risks including cancer, high blood pressure, liver damage, stomach bleeding and infection.

Xeljanz Blood Clot Risk

Xeljanz was approved in 2012 at a dose of 5mg twice daily for the treatment of rheumatoid arthritis. It was later approved for the treatment of psoriatic arthritis at the same 5mg twice daily dose and for ulcerative colitis at a dose of 5mg twice daily or 10mg twice daily.

A required post marketing study was conducted to further compare the use of Xeljanz 5mg twice daily, Xeljanz 10mg twice daily and the use of TNF inhibitor medications like Remicade and Humira. The study involved patients over the age of 50 who had at least one cardiac risk factor such as high blood pressure.

Initial study results showed an increased risk of venous thromboembolic events including pulmonary embolism (PE) and deep vein thrombosis (DVT) and an increased risk of death, particularly in the higher 10mg dosing group. For safety reasons, the patients from the higher dose group were moved to the 5mg twice daily dosing group but final results also confirmed a continued risk of death.

Results of the study and an accumulation of serious adverse event reports received by the FDA prompted the agency to issue a safety alert in February 2019. The warning stated that the use of Xeljanz or Xeljanz XR 10mg twice daily could increase the risk of potentially life-threatening clotting events such as PE or DVT. The FDA also required Pfizer to update prescribing information for Xeljanz to include blood clot warnings.

Venous Thromboembolic Events

Venous thromboembolic event is a blood clot that develops in the veins such as pulmonary embolism or deep vein thrombosis.

Pulmonary embolism occurs when a blood clot has formed or becomes lodged in the lungs. Symptoms of PE may include:

  • Irregular heartbeat
  • Chest pain
  • Difficulty breathing
  • Dizziness
  • Sweating
  • Coughing up blood

Deep vein thrombosis occurs when a blood clot forms or lodges in a deep vein, most commonly in the legs. Symptoms of DVT may include:

  • Pain
  • Swelling
  • Tenderness
  • Redness

DVT formation may increase the risk of a blood clot breaking free to travel to another area of the body including the lungs, heart or brain. Symptoms of DVT or PE should be treated by a medical professional right away.

Pulmonary Embolism

Despite the successful treatment of autoimmune disease for many patients, Xeljanz has been shown to increase the risk of death in some patients due to venous thromboembolic events (VTE). The U.S. Food and Drug Administration has said that hundreds of serious adverse event reports have been filed for blood clotting events including pulmonary embolism (PE) and deep vein thrombosis (DVT), some of which have resulted in death.

  • Symptoms of PE may include irregular heartbeat, chest pain, difficulty breathing, sweating, dizziness and coughing of blood.
  • Symptoms of DVT may include pain, swelling, tenderness or redness in affected area, usually the lower leg.

Either condition may be serious or life-threatening and should be reported to a health care professional immediately.

Other Xeljanz Side Effects

All medications cause side effects, most of which are not serious. Common side effects of Xeljanz may include:

  • Headache
  • Diarrhea
  • Increased blood pressure
  • Upper respiratory infection
  • Nasal or cold symptoms

Xeljanz may also cause side effects which are serious or may become serious. These may include:

  • Serious infections including viral, bacterial and fungal infections
  • Lymphoma or other cancer
  • Tuberculosis
  • Reactivation of Herpes or Hepatitis virus
  • Gastrointestinal perforation
  • Hypersensitivity or allergic reaction
  • Venous thromboembolic event such as PE or DVT

The FDA requires a “black box warning” to be included on all prescribing information for Xeljanz or Xeljanz XR which warns of the risk of serious infections and malignancies or cancers that may occur with Xeljanz use. All bothersome or persistent side effects should be reported to a health care professional. Any serious side effects, symptoms of PE or DVT or sudden symptoms should be reported right away and may warrant emergency medical treatment.

Xeljanz Lawsuit Claims

People who took Xeljanz or Xeljanz XR may be filing lawsuits against Pfizer for injuries caused by the medication. These events may include:

  • Venous thromboembolic events such as: Deep vein thrombosis (DVT) or Pulmonary embolism (PE)
  • Heart attack
  • Ischemic stroke
  • Cancer
    • breast cancer
    • lung cancer
    • pancreatic cancer
    • prostate cancer
    • melanoma
  • Sudden cardiac death
  • Death due to other cause

Medical injury lawsuits can provide compensation for medical costs, lost wages, pain and suffering and if the patient has died, for wrongful death. People or loved ones of those who have been injured or who died after taking Xeljanz or Xeljanz XR 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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