Xeljanz Under Safety Review for Health Canada

Xeljanz Linked to Increased Rick of Serious Heart-Related Issues and Cancer


Written by: Lauren Schwab, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.


Xeljanz, a popular drug used to treat moderate to severe rheumatoid arthritis as well as moderate to severe ulcerative colitis, is under evaluation by Health Canada after results from a clinical trial showed links between the drug and serious heart-related issues and cancer.

This is not the first time Xeljanz has been under review by Health Canada, however. In 2019, Xeljanz was linked to an increased risk of blood clots in the lungs and potentially death following the publication of the results of a clinical trial. Health Canada and the drug manufacturing company, Pfizer, worked together to update both the Xeljanz and Xeljanz XR label to include thrombosis in the warnings section.




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According to the April 6, 2021 Canadian safety alert, Pfizer and Health Canada are once again working together to evaluate the safety of Xejanz and Xeljanz XR:

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.

As previously mentioned on our February 2021 Drug Injury Watch blog article, "Xeljanz Has A New Drug Safety Issue, We Just Don't Know How Significant It Is, Yet", in the U.S., many experts are advocating for more research on the long-term effects of Xeljanz:

In our recent post, "Xeljanz FDA Drug Safety Communication in February 2021 Puts Heightened Scrutiny on Pfizer", we touched upon the two latest Xeljanz safety issues, Xeljanz causing heart problems and Xeljanz causing cancer. But there is still a lot that we do not know, yet, about how significant this new drug safety issue, or will be, for Xeljanz -- and Pfizer, the pharmaceutical company responsible for Xeljanz.

Be assured that we will continue to follow their coverage of Xeljanz as well as watch for possible FDA regulatory action concerning Xeljanz and Xeljanz XR.


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