KJ McElrath  |  May 14, 2021

Category: Legal News

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Woman with hand painWith a growing number of adverse event reports, patients are wondering: what are the side effects of Xeljanz, and how serious are they? What follows are some answers to questions about this medication and the risks of treatment.

What is Xeljanz?

Xeljanz (tofacitinib) is a prescription drug used for the treatment of moderate to severe rheumatoid arthritis. It may be prescribed alone, or in combination with other medications, including Trexall or Rheumatrex (methotrexate). It is also used for patients who fail to respond to other treatments. The compound was developed in the 1990s by the National Institutes of Health in conjunction with Pfizer. Xeljanz is administered orally, twice daily.

What are the Indications for Xeljanz?

Aside from rheumatoid arthritis, Xeljanz is prescribed for psoriatic arthritis and ulcerative colitis. For the last few years, some physicians have been willing to write “off-label” prescriptions for Xeljanz to treat alopecia, although this particular use is highly controversial in light of the severity of some side effects of Xeljanz. In addition, the drug is being studied for the treatment of inflammatory bowel disease and as an anti-rejection drug for organ transplant patients.

How Does Xeljanz Work?

Xeljanz is one of a class of medications known as janus kinase (JAK) inhibitors. Its mechanism of action is to prevent biochemical communications between cell proteins that are part of immune function, mitosis (cell reproduction), cell death and the formation of tumors (not surprisingly, some medications of this class are used for chemotherapy). Xeljanz is essentially works by suppressing the immune system. While this addresses the primary cause of rheumatoid arthritis, it also leaves the patient vulnerable to infections.

What are the Side Effects of Xeljanz?

The side effects of Xeljanz can be categorized as common or serious. The more common side effects of Xeljanz are:

  • diarrhea
  • headache
  • elevated blood pressure
  • upper respiratory tract infections
  • cold symptoms

These side effects occurred in more than 2 percent of patients who took the medication. Serious side effects include:

  • serious infections (bacterial, viral and fungal)
  • tuberculosis
  • lymphoma and other cancers
  • genetic mutations
  • sterility

Xeljanz may also carry with it a risk of developing a pulmonary embolism (PE), which happens when blood clots form in the lungs. The FDA issued an alert for PE on Feb. 25, 2019.

In February 2021, the FDA issued a safety warning about an increased risk of serious heart-related problems and cancer from Xeljanz use when compared with other medications. This warning is based on preliminary results—the final results of the clinical safety trial are not yet available.

These serious side effects are the reason that the European Medicines Agency (the EU counterpart to the FDA) did not approve Xeljanz. In the US, the FDA has required the product to carry a “black box” warning regarding the risks of injury and death.

I Was Injured by Taking Xeljanz. What Should I Do?

Law firms are currently seeking clients who suffered embolism as a result of taking Xeljanz. Since the FDA published the results of the recent safety study, questions have been raised about whether or not Pfizer was aware, or should have known, of the danger of PE associated with Xeljanz. An experienced drug litigation attorney can help determine if you have a case and what you may be eligible to recover.

If you or someone close to you suffered a pulmonary embolism, deep vein thrombosis, or died after taking Xeljanz or Xeljanz XR, you may benefit from participating in a free Xeljanz blood clot lawsuit investigation. Learn more by filling out the short form on this page. 

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This article is not legal advice. It is presented 
for informational purposes only.

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