The arthritis drug Xeljanz is one of the most popular drug used to treat rheumatoid arthritis. Unfortunately, Xeljanz has been linked with serious complications, including blood clot problems that can potentially become fatal.

What is Xeljanz?

Xeljanz (also known by its generic name, tofacitinib) is manufactured by pharmaceutical giant Pfizer Inc., and was first approved by the U.S. Food and Drug Administration (FDA) on Nov. 6, 2012.

RA drug Xeljanz belongs to a class of drugs known as Janus kinase (JAK) inhibitors, and is taken orally in tablet form. It works by blocking the activity of certain enzymes that affect the functioning of the immune system.

What Uses has the FDA Approved Xeljanz For?

Xeljanz’s most common use is to treat rheumatoid arthritis, which the FDA approved it for in 2012 for adults who did not respond well to treatment with methotrexate.

The FDA has also approved this drug for two other auto-immune conditions. In 2017, it was approved as a treatment for psoriatic arthritis in those who did not respond well to other treatments, and in 2018 for patients with ulcerative colitis (UC).

Rheumatoid arthritis is a chronic inflammatory disease affecting the joints, surrounding tissues, and even other organ systems. Psoriatic arthritis is a version of arthritis that includes the chronic skin condition psoriasis. Ulcerative colitis is an inflammatory disease of the large intestine and rectum, causing bloody diarrhea.

Xeljanz is sometimes used in a combination with other arthritis drugs like methotrexate.

What are the Risks of Xeljanz?

Despite the FDA’s approval of Xeljanz, the federal agency is now investigating major risks associated with the drug in rheumatoid arthritis patients. According to the FDA, a safety clinical trial required as a condition of its initial approval found that rheumatoid arthritis patients taking Xeljanz at a twice-daily dose of 10 mg faced an increased risk of blood clots in the lungs and even threat of death.

It is important to note that the FDA has not approved the use of Xeljanz at this twice-daily dosage of 10 mg for patients with rheumatoid arthritis. The federal agency has only approved that size dosage for patients with ulcerative colitis. In fact, the FDA had a warning label added to Xeljanz in 2019.

Blood clot–related conditions that patients may be faced with include pulmonary embolism and deep vein thrombosis.

Patients currently taking tofacitinib should not stop taking it or change their dosage without first consulting a doctor. If you experience symptoms of a blood clot—such as sudden shortness of breath, difficulty breathing, chest pain or back pain, coughing up blood, excessive sweating, or clammy or bluish skin—seek immediate medical attention.

The drug’s manufacturer, Pfizer, is transitioning patients involved in the clinical trial who were formerly on the 10 mg twice a day dose to a 5 mg dose twice a day, a dosage currently approved by the FDA. However, after changes were made to Xeljanz doses to better protect patients from potential blood clot risks, new data has complicated the image of Xeljanz’s safety. Though the new dosing presents a hopeful picture for Xeljanz users, more information is still needed.

Helio Gastroenterolgy reports that a new study conducted by researchers at the inflammatory bowel disease center at the University of California- San Diego (UCSD) indicted that patients who took Xeljanz for UC had no greater a risk of of developing deep vein thrombosis or pulmonary embolism than those who did not take the medication. However, lead researcher Dr. William J. Sandborn cautioned against too much optimism.

In presenting the data the American College of Gastroenterology Annual Meeting, Dr. Sandborn noted that “on one level, these data are somewhat reassuring.” He went on to say “on the other hand, we still have a relatively small sample size. We should not over interpret these findings.” He stressed that more information was needed, because of the nature of the study.

He cautioned medical professionals to still heed the reduced dosage warnings, in order to lessen the possible risks while still deriving benefits from Xeljanz’s use.

The UCSD study examined multiple groups of patients who took both the 10 mg twice a day dose and the 5 mg twice a day dose, compared to those patients who did not take Xeljanz. Dr. Sandborn stated that in the study, incidents of deep vein thrombosis and pulmonary embolism were comparable in patients who took Xeljanz and those who did not take the drug.

Filing a Xeljanz Lawsuit

If you or someone you love has suffered from Xeljanz side effects or blood clot injuries like pulmonary embolism or deep vein thrombosis after taking Xeljanz, you may be able to file a lawsuit and pursue compensation.

Of course, filing a lawsuit cannot undo the pain and suffering caused by Xeljanz side effects, but it can at least help to alleviate the financial burden caused by medical expenses, lost wages, and more.

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