Recommends That Xeljanz Should Be Used With Caution In Patients At High Risk Of Blood Clots As Well Aa In Patients Older Than 65 Years Of Age
On October 30, 2019 the European Medicines Agency (EMA) issued a new Xeljanz warning which states the drug could increase the risk of blood clots resulting in pulmonary embolism (PE) and deep vein thrombosis (DVT).
As background, on February 21, 2019 we posted this article, "Xeljanz Recommended Dosage For Ulcerative Colitis Patients May Increase Risk Of Pulmonary Embolism". We updated that article a few days later with this February 25, 2019 FDA Drug Safety Communication: "Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate".
As regards the recent Xeljanz EMA regulatory action, we get the following details from this PDF document, "Xeljanz to be used with caution for all patients at high risk of blood clots":
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.
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Back in May 2019 there was an EMA press release about Xeljanz, "Restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs", that previewed this
EMA’s safety committee (PRAC) is recommending that doctors must not prescribe the 10 mg twice daily dose of Xeljanz (tofacitinib) in patients who are at high risk of blood clots in the lungs. These include patients who have heart failure, cancer, inherited blood clotting disorders or a history of blood clots, as well as patients who take combined hormonal contraceptives, are receiving hormone replacement therapy or are undergoing major surgery.
In addition, doctors should consider other factors that may increase the risk of blood clots in the lungs including age, obesity, smoking or immobilisation.
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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