JAK inhibitors must include heart risks in labels, Health Canada

OTTAWA — Health Canada says it is working with manufacturers to ensure Canadian labelling for JAK inhibitors includes the risks of serious heart-related problems, fatal blood clots and cancer.

The substances named under a public advisory include Cibinqo, Inrebic, Jakavi, Olumiant, Rinvoq and Xeljanz/Xeljanz XR.

Health Canada has advised members of the general population to consult with their health care professionals if they have concerns about the use of JAK inhibitors.

Currently, manufacturers are working to update all Canadian labelling for all Janus Kinase inhibitors so that they reflect 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.

Below is a list of the products included in this process:

• CIBINQO
• INREBIC
• JAKAVI
• OLUMIANT
• RINVOQ
• XELJANZ/ XELJANZ XR

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 says it 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.