The final results of a clinical trial conducted with XELJANZ showed higher risks of MACE, thrombosis, malignancy, serious infections and fatal events, compared to TNFi, a group of medicines that suppress the body's natural response to tumor necrosis factor (TNF), in RA patients. Furthermore, preliminary results from a retrospective observational study suggest OLUMIANT is associated with higher risks of MACE and thrombosis when compared to TNFi in RA patients. Based on these safety findings and similar mechanisms of action, Health Canada cannot rule out the risks of MACE, thrombosis (including fatal events) and malignancies, for other JAK inhibitors (CIBINQO , INREBIC, JAKAVI, OLUMIANT, and RINVOQ) . As a precautionary measure, Health Canada is working with the manufacturers to update and align these risks in the CPMs for JAK inhibitors.
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