European and Canadian authorities move to limit risk from JAK inhibitors

[Baricitinib image courtesy of PubChem]

The European Medicines Agency (EMA) is backing a series of measures to reduce the risk of serious side effects associated with Janus kinase (JAK) inhibitors, limiting their use in high-risk individuals.

Similarly, Health Canada is recommending updated labeling for the drug class to disclose the risk of serious cardiovascular events and cancer. The agency is working with Novartis (NYSE:NVS) to update Jakavi’s (ruxolitinib) labeling. Health Canada has already worked with manufacturers to update the labeling for the JAK drugs Cibinqo (abrocitinib), Inrebic (fedratinib), Olumiant (baricitinib,), Rinvoq (upadacitinib) and Xeljanz/Xeljanz XR (tofacitinib).

In 2021, FDA announced that it would require a warning for JAK inhibitors, indicating that they may lead to an elevated risk of cardiovascular events, cancer, blood clots and death.

Health Canada recommende…

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