U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Drug Safety and Availability
  4. FDA Drug Safety Podcasts
  5. Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)
  1. FDA Drug Safety Podcasts

Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)

FDA Drug Safety Podcast

Listen

Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.

On February 4, 2021, FDA alerted the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (active ingredient tofacitinib) compared to another type of medicine called tumor necrosis factor (or TNF) inhibitors. FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available.

We will evaluate the clinical trial results we have received to date and will work with the drug manufacturer to obtain further information as soon as possible. We will communicate our final conclusions and recommendations when we have completed our review or have more information to share. Health care professionals should consider the benefits and risks of tofacitinib when deciding whether to prescribe or continue patients on the medicine. Continue to follow the recommendations in the tofacitinib prescribing information.

Health care professionals should consider the benefits and risks of tofacitinib when deciding whether to prescribe or continue patients on the medicine. Continue to follow the recommendations in the tofacitinib prescribing information.

When FDA first approved tofacitinib in 2012 to treat adults with rheumatoid arthritis (or RA) who did not respond well to methotrexate, a TNF inhibitor, we required the manufacturer, Pfizer, to conduct a safety clinical trial in patients with RA to evaluate the risk of serious heart-related events, cancer, and infections. The trial studied two doses of tofacitinib (5 mg twice daily, the approved dosage for RA, and a higher 10 mg twice daily dosage) in comparison to patients taking methotrexate. Patients in the trial were required to be at least 50 years old with at least one cardiovascular risk factor.

In February 2019 and July 2019, we warned that interim trial results showed an increased risk of blood clots and death with the higher 10 mg twice daily dosage, and as a result, approved a Boxed Warning to the tofacitinib prescribing information. The clinical trial is now complete and initial results show a higher occurrence of serious heart-related events and cancer in RA patients treated with both doses of tofacitinib compared to patients treated with a TNF inhibitor. FDA is awaiting additional results from the trial.

Side effects involving tofacitinib should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov and follow us on Twitter @FDA_Drug_Info. Thanks for listening.

Related Information

Back to Top