Health Canada is informing Canadians and health care professionals that it is conducting a safety review of Xeljanz and Xeljanz XR (tofacitinib) after a clinical trial identified an increased risk of serious heart-related issues and cancer in trial participants.

Xeljanz and Xeljanz XR (tofacitinib) is a prescription drug used to treat adults with moderate to severely active rheumatoid arthritis, active psoriatic arthritis, or moderate to severely active ulcerative colitis who have not responded well to other medications.

The clinical trial investigated the long-term safety of Xeljanz and Xeljanz XR (tofacitinib) at two doses (5 mg twice a day and 10 mg twice a day) in patients with rheumatoid arthritis, who are at least 50 years of age and have at least one cardiovascular risk factor. Pfizer, the manufacturer of the drug, conducted the trial in multiple countries, including Canada.

The current Canadian label includes serious warnings and precautions for cancer and information on heart attacks, which were the most frequently reported serious heart-related problems in this trial.

Health Canada has not authorized the sale of the higher dose of 10 mg twice a day for rheumatoid arthritis or psoriatic arthritis; this dose is only authorized for patients with ulcerative colitis who have not responded well to other medications. For patients with ulcerative colitis, the Canadian prescribing information recommends that they use the lowest effective dose possible to lower the risk of adverse reactions.

Previously, Health Canada had conducted a safety review of this drug after increased risks of blood clots in the lungs and death were discovered during a clinical trial. Following this safety review in 2019, Health Canada worked with Pfizer to update the Canadian labelling for Xeljanz and Xeljanz XR (tofacitinib) to include thrombosis as a warning, and informed Canadians and health care professionals of the findings.

Health Canada is working with Pfizer to evaluate the available safety information for Xeljanz and Xeljanz XR (tofacitinib) and will inform the public of any new safety findings, as needed, once the review is completed.

If you are a patient taking Xeljanz/Xeljanz XR (tofacitinib):

• Do not stop or change your dose of Xeljanz or Xeljanz XR (tofacitinib) without first talking to your health care professional.

If you are a health care professional:

• Consider the benefits and risks of Xeljanz and Xeljanz XR (tofacitinib) when deciding whether to prescribe or keep patients on the drug.
• Follow the recommendations in the Xeljanz and Xeljanz XR (tofacitinib) product monograph for the specific condition you are treating.
• Report health or safety concerns.

To report a side effect to a health product to Health Canada:

• Call toll-free at 1-866-234-2345.
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Health Canada
(613) 957-2983
[email protected]

(613) 957-2991
1-866 225-0709
[email protected]