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04-11-2019 | Tofacitinib | News

Regulatory update

EMA issues updated advice on VTE risk with tofacitinib


medwireNews: The EMA has recommended that the Janus kinase (JAK) inhibitor tofacitinib should be used with caution in patients at high risk for venous thromboembolism (VTE).

This announcement is based on the results of a safety review, and updates an earlier safety alert warning that the recommended 5 mg twice-daily dose should not be exceeded when treating rheumatoid arthritis.

The EMA’s safety review evaluated data from an ongoing study finding that patients taking either the 5 mg or 10 mg twice daily dose had a higher risk for pulmonary embolism and deep vein thrombosis than those taking tumor necrosis factor inhibitors. When the committee analyzed these results together with all available data, the association between tofacitinib use and VTE risk was particularly evident for the 10 mg twice-daily dose, currently approved for ulcerative colitis.

People considered at high risk for VTE include those with heart disease, cancer, inherited blood-clotting disorders, or a history of VTE, as well as people taking hormonal contraceptives and those who are immobile.

In accordance with the US label update in July 2019, the EMA says it will update the European product information with new warnings and recommendations, and will list VTE as an uncommon side effect that occurs in 0.1–1.0% of patients treated with the JAK inhibitor.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group