Xeljanz Safety Alert for People Who Are (1) Older, (2) Current / Past Smokers, or (3) With Cardiovascular or Cancer Risk Factors

 

(Posted by Tom Lamb at Drug Injury Watch)

 

The drug regulatory agency Health Canada issued this news release item on January 12, 2022, which points out the results of their recent examination of some serious side effects associated with Xeljanz: “Advisory – Health Canada safety review finds link between the use of Xeljanz and Xeljanz XR (tofacitinib) and increased risk of serious heart-related issues and cancer“. This January 2022 Health Canada news release is the latest development concerning Xeljanz drug safety, Xeljanz side effects, and Xeljanz warnings, topics which we began reporting on back in early 2019, starting with this article, “Xeljanz Recommended Dosage For Ulcerative Colitis Patients May Increase Risk Of Pulmonary Embolism“.

This excerpt from the January 2022 Health Canada Xeljanz Advisory document provides an overview of the Xeljanz drug safety issue, and how the Xeljanz side effects risks may also apply to Olumiant and Rinvoq:

Health Canada completed a safety review that confirmed a link between the use of Xeljanz/Xeljanz XR and the increased risks of serious heart-related problems and cancer, especially in older patients, patients who are current or past smokers, and patients with cardiovascular or cancer risk factors. Health Canada’s review also found that all patients treated with Xeljanz 10 mg twice daily had a higher risk of death, blood clots and serious infections, compared to patients treated with Xeljanz 5 mg twice daily or tumour necrosis factor inhibitors (TNFi)….

Health Canada has also initiated a new safety review of the potential risks of serious heart-related problems, cancer and blood clots with two other drugs of the same class as Xeljanz/Xeljanz XR (i.e. Olumiant and Rinvoq) that work similarly for the treatment of similar diseases.

As background, Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib) are Janus kinase (JAK) inhibitors. Xeljanz is a Pfizer drug, Olumiant is an Eli Lilly drug, and Rinvoq is an AbbVie drug.

The Health Canada Xeljanz Advisory gives some more detailed information in a section intended for healthcare professionals but, no doubt, of interest to patients using Xeljanz — as well as Olumiant or Rinvoq, perhaps:

  • Inform patients that Xeljanz/Xeljanz XR may increase their risk of major adverse cardiovascular events including non-fatal myocardial infarction. Instruct all patients, especially geriatric patients, current or past smokers, or patients with other cardiovascular risk factors, to be alert for signs and symptoms of cardiovascular events.
  • Inform patients that Xeljanz/Xeljanz XR may increase their risk of certain cancers, and that lung cancer, lymphoma and other cancers have been observed in patients taking Xeljanz. Instruct patients to inform their healthcare provider if they have ever had any type of cancer.

Our law firm is investigating possible drug injury lawsuits for patients who used Xeljanz, Olumiant, or Rinvoq and then suffered one of the serious side effects associated with these JAK inhibitors drugs. In particular, heart problems such as heart attacks, strokes, pulmonary embolism (PE), and deep vein thrombosis (DVT), as well as cancers such as lymphoma and lung cancer.

We will continue to watch for further developments concerning Xeljanz drug safety, Xeljanz side effects, and Xeljanz warnings in the drug regulatory sector.


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