Xeljanz May Be Linked to Serious Heart-Related Issues and Cancer
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Health Canada has issued a safety review of Xeljanz and Xeljanz XR -- relatively new drugs commonly used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis -- due to a clinical trial that showed an increased risk of serious heart-related issues and cancers when taking these drugs.
According to an April 2021 alert from Health Canada, "Health Canada has initiated a safety review on Xeljanz and Xeljanz XR (tofacitinib), used to treat arthritis and ulcerative colitis", Health Canada is working with Pfizer, the drug manufacturer, to inform the public about new drug safety findings:
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.
Individuals currently taking Xeljanz should continue to do so, and should not stop or change their dosage of Xeljanz without speaking to their healthcare professional first.
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This recent safety alert from Health Canada echoes concerns voiced by the Food and Drug Administration (FDA) in early February 2021. In this Drug Injury Watch article, "Xeljanz FDA Drug Safety Communication in February 2021 Puts Heightened Scrutiny on Pfizer", we covered the FDA's plans on how to address the Xeljanz safety concerns:
In early February 2021 the FDA doubled-down on these two Xeljanz safety issues: (1) Xeljanz causing heart problems; and (2) Xeljanz causing cancer. This FDA Drug Safety Communication, "Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)", provided the latest details about these "not-new" Xeljanz safety issues. And what I mean by this characterization is there was already a so-called Black Box Warning that points out reports of Xeljanz causing heart problems and Xeljanz causing cancer which was added to the Xeljanz drug label back in July 2019.
At that time, it was unclear what action the FDA was going to take regarding these concerns, and a February 4, 2021, MedPage Today news report, "No Xeljanz Plan Yet From FDA", reported the FDA was not yet prepared to take action.
Be assured that we will continue to follow this latest Xeljanz drug safety issue as well as watch for possible further FDA regulatory actions, including a possible Xeljanz recall.
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