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Xeljanz Lawsuits

Patients who took Xeljanz for rheumatoid or psoriatic arthritis or ulcerative colitis and consequently had blood clots, heart problems or cancer may be eligible to file a lawsuit with a Xeljanz attorney. The FDA warns that Xeljanz may increase the risk of blood clots, heart problems and cancer.

Last Modified: May 17, 2024
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Latest Xeljanz Lawsuit Updates

As of June 2024, Drugwatch’s legal partners are not accepting Xeljanz lawsuits.

Individual lawsuits thus far filed, have been on behalf of patients who suffered blood clots, cardiovascular problems or cancer after taking Xeljanz for rheumatoid arthritis, psoriatic arthritis or ulcerative colitis. Xeljanz (tofacitinib) has not been recalled, but the U.S. Food and Drug Administration published a safety alert associated with adverse events in February 2021.

  • April 2023: Researchers presented findings demonstrating Janus kinase inhibitors, including Xeljanz, lead to an increase in malignancy.
  • January 2023: The Annals of the Rheumatic Diseases published a study showing a greater risk of major adverse cardiovascular events using tofacitinib versus tumor necrosis factor inhibitors in patients with rheumatoid arthritis.
  • October 2022: The European Medicines Agency recommended the use of Xeljanz be restricted to minimize the risk of serious cardiovascular conditions, blood clots, cancer and other infections.
  • September 2021: The FDA required a new heightened Xeljanz warning for increased risk of serious cardiovascular events such as heart attack or stroke, cancer, blood clots and even death.
  • February 2021: The FDA warned about potential links between Xeljanz and an increased risk of cancer and serious heart-related events.

Why Are Xeljanz Lawsuits Being Filed?

People with rheumatoid arthritis, psoriatic arthritis and ulcerative colitis patients who took Xeljanz or Xeljanz XR are filing lawsuits after they developed a blood clot in the legs, thigh, pelvis or lungs. The medical term for blood clots in the lungs is pulmonary embolism. Doctors refer to the other type of clots as deep vein thrombosis.

The FDA approved Xeljanz in 2012 for moderate to severe rheumatoid arthritis. Later, the FDA approved the drug for psoriatic arthritis and ulcerative colitis. In February 2019, the FDA released a safety alert warning of an increased risk of blood clots and death. Next, the agency approved a black box warning about the risks. In 2021, the FDA required an even-stronger boxed warning for very serious heart-related events such as heart attack or stroke.

Arkansas resident Marilyn Stube filed a lawsuit against Pfizer in July 2019. After taking Xeljanz for arthritis for four years, Stube went into septic shock, resulting in the amputation of all four of her limbs. The lawsuit claims Pfizer did not adequately warn doctors and patients and failed to notify the FDA of the possibility of adverse reactions to the drug.

Xeljanz Linked to Blood Clots

Since the FDA announced the increased risk of blood clots with Xeljanz in February 2019, Xeljanz attorneys have filed lawsuits for patients who took the drug and had pulmonary embolisms and/or deep vein thrombosis. These types of blood clots can be life-threatening. Patients noticing these symptoms should seek immediate medical attention.

These are signs of key blood clot types:
  • Pulmonary Embolism: Fast or irregular heartbeat; difficulty breathing; chest discomfort or pain, especially if it worsens with a deep breath or cough; very low blood pressure, usually perceived as light-headedness or fainting; coughing up blood
  • Deep Vein Thrombosis: Swelling in the affected area; tenderness or pain; redness in the skin

Doctors may treat clots with compression stockings, medications or surgery. To prevent future clots, some patients may need medications for the rest of their lives.

As of January 2024, the public dashboard of the FDA’s Adverse Event Reporting System has received 132,469 reports of adverse events involving Xeljanz. Serious cases totaled 54,826, including 4,104 deaths. In December 2021, the FDA published additional warnings about an increased risk of cancer, serious heart-related events and death.

Cardiovascular Problems

In February 2021, the FDA updated its drug safety communication to alert the public that initial safety trials linked Xeljanz to an increased risk of serious cardiovascular events.

Cardiovascular problems linked to Xeljanz lawsuits include:
  • Cardiac arrest
  • Cardiovascular death
  • Congestive heart failure
  • Coronary revascularization
  • Myocardial infarction

According to a January 2021 statement from Pfizer, the most reported cardiovascular event in the trials was heart attack.

Cancer

The FDA’s February 2021 drug safety communication also warned that initial results from the safety trials signaled an increased risk of cancer. Excluding nonmelanoma skin cancer, the risks of cancers were higher with Xeljanz in safety endpoint trials.

Cancers linked to Xeljanz lawsuits include:
  • Breast
  • Colon
  • Gastric
  • Lung
  • Melanoma
  • Non-Hodgkin lymphoma
  • Pancreatic
  • Prostate
  • Renal cell carcinoma
  • Thyroid

Recent research shows an increased cancer risk among patients taking higher doses of Xeljanz. A 2022 study in The New England Journal of Medicine reported a 48% increased cancer risk in patients taking higher doses.



Can You File a Xeljanz Lawsuit?

You may be eligible to make a claim and file a Xeljanz lawsuit. If you have used Xeljanz and have experienced deep vein thrombosis, pulmonary embolism, serious cardiovascular events or cancers because of taking it, and you can document the medical diagnosis linked to your use of the drug, you will likely have a claim.

The medical diagnosis will help you pursue a lawsuit. You will also need to find a qualified Xeljanz attorney who specializes in drug and medicine lawsuits to review your case.

Xeljanz Lawsuit Settlement Payouts

Xeljanz attorneys are currently accepting individual lawsuits rather than class-action suits. If successful, payouts may be made for economic damages, noneconomic damages or both. Economic damages include current and future medical expenses, lost income and reduced earning capacity. Noneconomic damages include the effects of physical and mental pain as well as the loss of enjoyment of life.

Settlement amounts depend on the impact to the individual’s life and health, the severity of adverse effects and the degree of economic loss. State laws and regulations, the availability of evidence and the results of other trials may also impact settlements.



Please seek the advice of a medical professional before making health care decisions.