FDA Finds Increased Risk of Blood Clots in Lungs in RA Patients Taking Xeljanz at Higher Doses in Clinical Trials

Last updated: September 2020

The United States Food and Drug Administration (FDA) recently announced that safety drug trials have found an increased risk of blood clots in the lungs and death in Rheumatoid Arthritis (RA) patients who are taking tofacitinib (Xeljanz, Xeljanz XR) at a10 mg twice daily dose.1 Currently the 10 mg twice daily dose is only approved for patients who have Ulcerative Colitis (UC).2

Safety Trials

When a medication is approved for use in a new disease, the FDA requires that the manufacturer to make sure that the medication is safe for use for all patients who have this disease. The sponsor will enroll patients of different age ranges, patients with other diseases, and/or patients taking other medications, to make sure that the trial drug is safe for anyone to take and will not lead to other infections, cancers or heart-related events.1

One of the safety trials compared the use of 10 mg of tofacitinib twice daily versus 5 mg of tofacitinib twice daily in RA patients who were 50 years old or older, had at least one cardiovascular risk factor, and who were taking methotrexate as well as a medication classified as a Tumor Necrosis Factor (TNF) inhibitor.1 The study found that patients taking 10mg twice daily were more likely to experience blood clots in the lungs (also known as a pulmonary embolism) than patients on the 5 mg twice daily dose.1 The study is now currently transitioning all study patients to the lower, safer 5 mg twice daily dose2.

*If you are taking tofacitinib, you should not stop or change your dose without talking to your health care professional first.*

How does this affect me?

This finding probably will not affect you, unless you have both RA and UC. Currently, this increased blood clot risk has been found in one very specific population of RA patients taking tofacitinib. Tofacitinib has been tested in patients with UC and is considered safe. If you have concerns about your dose of tofacitinib, you should talk with your health care team. It is good to be aware of the symptoms of blood clots in the lungs and you should seek medical attention immediately if you experience any of these symptoms.

What are the symptoms of blood clots in the lungs?

The symptoms of pulmonary embolism include1,2,3:

  • Shortness of breath or difficulty breathing that happens suddenly.
  • Back or chest pain. This pain may get worse when you take a deep breath but usually doesn’t go away when you rest.
  • Coughing, especially if you cough up blood.
  • Sweating excessively
  • Skin that is bluish in color, and is sticky or sweaty (clammy)

Pulmonary embolisms can be caused by many different medical conditions.3 If you are worried about your risk of pulmonary embolism, talk to your health care team to discuss your options for treatment.

New warnings

At the end of July, the FDA approved new warnings about the increased risk of blood clots and added a Boxed Warning for the medication. The approved use of tofacitinib for ulcerative colitis will also be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines.4

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