Public advisory

Canadian labelling for all JAK inhibitors to include risks of serious heart-related problems, fatal blood clots and cancer

Last updated

Summary

Product
Janus Kinase (JAK) inhibitors, including: Cibinqo, Inrebic, Jakavi, Olumiant, Rinvoq and Xeljanz/Xeljanz XR.
Issue
Health products - Labelling
What to do

Consult with your health care professional if you have concerns about the use of JAK inhibitors.

Affected products

Brand Name Medicinal Ingredients Available Formulations
CIBINQO abrocitinib 50 mg, 100 mg, and 200 mg tablets
INREBIC fedratinib 100 mg capsules
JAKAVI ruxolitinib 5 mg, 10 mg, 15 mg and 20 mg tablets
OLUMIANT baricitinib 2 mg tablets
RINVOQ upadacitinib 15 mg and 30 mg extended-release tablets
XELJANZ/ XELJANZ XR tofacitinib 5 mg and 10 mg tablets
11 mg extended-release tablets

Issue

The Canadian labelling for all Janus Kinase (JAK) inhibitors is being updated to include the risks of serious heart-related problems, fatal blood clots and cancer. This is being done as a precautionary measure. To date, Canadian labelling for the drugs Cibinqo, Inrebic, Olumiant, Rinvoq and Xeljanz/Xeljanz XR have been revised. Health Canada is working with the manufacturer of Jakavi to update its Canadian labelling.

JAK inhibitors are prescription drugs authorized for sale in Canada for various inflammatory disorders, certain blood cancers and graft-versus-host disease.

These labelling updates are the result of a number of safety reviews conducted by Health Canada. In 2020 and 2021, Health Canada assessed and confirmed the risks of serious heart-related problems, fatal blood clots, and cancer with Xeljanz/Xeljanz XR. The Department also assessed whether these risks would apply to Olumiant and Rinvoq, which are also used for inflammatory conditions. Based on these findings and how these drugs work, Health Canada cannot rule out these risks for other JAK inhibitors. Therefore, as a precautionary measure, Health Canada is working with manufacturers to ensure Canadian labelling of all JAK inhibitors includes these risks.

Health Canada will continue to monitor safety information on JAK inhibitors, as it does for all health products on the Canadian market, to identify and assess potential harms. The Department will take appropriate and timely action should new health risks be identified.

What you should do

  • Talk to your health care professional for more details about this new safety information.
  • Talk to your health care professional about possible heart disease risk factors before starting a JAK inhibitor.
  • Contact your health care professional immediately and stop taking your JAK inhibitor if you develop symptoms of a heart problem. Symptoms may include:
    • new or worsening chest pain;
    • shortness of breath;
    • irregular heartbeats; or
    • swelling of the legs.
  • Talk to your health care professional if you have or have had any type of cancer before taking a JAK inhibitor.
  • Talk to your healthcare professional if you are a current or past smoker.
  • Be aware that blood clots in the veins of the arms or legs (deep vein thrombosis), arteries (arterial thrombosis) or lungs (pulmonary embolism) can happen in some patients taking a JAK inhibitor. This may be life-threatening and can cause death.
  • Stop taking your JAK inhibitor and seek immediate medical help if you develop any symptoms of a blood clot in your arms or legs (such as swelling, pain or tenderness in the arm or leg), or your lungs (such as sudden unexplained chest pain or shortness of breath).

If you are a health care professional:

  • Consider the benefits and risks, and consult the safety information in the Canadian labelling, prior to initiating or continuing therapy with a JAK inhibitor, particularly in geriatric patients, in patients who are current or past smokers, those with other cardiovascular or malignancy risk factors or an underlying malignancy, those who develop a malignancy, and in patients who may be at increased risk of thrombosis.
  • Inform patients that JAK inhibitors may increase their risk of major adverse cardiovascular events, including non-fatal myocardial infarction. Instruct all patients, especially geriatric patients, current and past smokers, and patients with other cardiovascular risk factors, to be alert for the symptoms of stroke and cardiovascular events.
  • Advise patients to stop taking their JAK inhibitor and seek immediate medical help if they develop symptoms of a heart problem.
  • Inform patients that JAK inhibitors may increase their risk for certain cancers, such as lung cancer and lymphoma. Instruct patients to inform their healthcare provider if they have a history of any type of cancer.
  • Advise patients to stop taking their JAK inhibitor and to seek immediate medical help if they experience any symptoms of thrombosis.

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.

Additional information

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products - Drugs
Companies
Published by
Health Canada
Audience
General public
Health professionals
Identification number
RA-72146
Media and public enquiries

Media enquiries
Health Canada
613-957-2983
media@hc-sc.gc.ca

Public enquiries
613-957-2991
1-866-225-0709
info@hc-sc.gc.ca

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