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Picture of Researcher: Ariana Arce​

Researcher: Ariana Arce​


Picture of Journalist: Aaron Vivanco

Journalist: Aaron Vivanco


Picture of Editor: Daniela Polo

Editor: Daniela Polo


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The use of the rheumatoid arthritis medication Xeljanz (generic: tofacitinib) has been linked to a significantly increased risk of serious side effects, including blood clots in the lungs (pulmonary embolism), cancer, opportunistic infections, liver damage, and even death.

Xeljanz Side Effects

February 2022: A study published in the New England Journal of Medicine underscores a key claim that plaintiffs are making in these lawsuits: there is a greater incidence of adverse cardiovascular events and cancer associated with Xeljanz than with other treatment options.
January 11, 2022: A mass tort claim was filed against Xeljanz-manufacturer Pfizer. At high doses, Xeljanz can cause serious side effects, including the following:

  • Blood clots in the lungs, pelvis, thighs, or legs
  • Pulmonary embolisms
  • Liver damage
  • Cancer

September 1, 2021: The Food and Drug Administration issued an update requiring a modified black box warning on Xeljanz disclosing potential risks of cancer and cardiac events. The current warning mentions the following:

  • Serious infections leading to hospitalization
    • Active tuberculosis
    • Invasive fungal infections, including cryptococcosis and pneumocystosis
    • Bacterial and viral infections, including herpes zoster
  • Mortality
    • Patients with rheumatoid arthritis aged 50 years and older with at least one cardiovascular (CV) risk factor treated with 10-mg Xeljanz twice a day had a higher rate of all-cause mortality
  • Malignancy
    • Occurrence of lymphoma and other malignancies in patients treated with Xeljanz
    • Occurrence of Epstein–Barr virus-associated posttransplant lymphoproliferative disorder in patients who have undergone renal transplant
  • Thrombosis
    • An increased incidence of thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, has been observed in patients with rheumatoid arthritis aged 50 years and older with at least one CV risk factor treated with 10-mg Xeljanz twice daily compared with those treated only with a 5-mg dose twice daily

Xeljanz Legal Cases

Several hundred Xeljanz lawsuits are being investigated, and it is likely that complaints will be filed against Pfizer throughout 2022 for failing to warn about the potential side effects of Xeljanz and Xeljanz XR.
Preliminary data from a study released in February 2021 found an increased incidence of cancer associated with the use of Xeljanz. Although full information about the potential cancer risk has not been released, lawsuits are being pursued for various cancers that may be caused by Xeljanz, including cancers of the breast, colon, prostate, pancreas, lung (among prior nonsmokers), non-Hodgkin’s lymphoma, and others.