There is a new Xeljanz drug safety warning about an increased risk of blood clots resulting in pulmonary embolism (PE) and deep vein thrombosis (DVT).
From this PDF document, “Xeljanz to be used with caution for all patients at high risk of blood clots”, issued in October 2019 by the European Medicines Agency (EMA), we get these details:
A review by EMA’s safety committee (PRAC) has concluded that Xeljanz (tofacitinib) could increase the risk of blood clots in the lungs and in deep veins in patients who are already at high risk.
As a result, the PRAC is recommending that Xeljanz should be used with caution in patients at high risk of blood clots. In addition, the maintenance doses of 10 mg twice daily should not be used in patients with ulcerative colitis who are at high risk unless there is no suitable alternative treatment. Further, the PRAC is recommending that patients older than 65 years of age should be treated with Xeljanz only when there is no alternative treatment.
Of course, we will continue to monitor the drug safety profile of Xeljanz in the US and Europe. In particular, we will watch for Xeljanz adverse events involving a deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
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