The PRAC 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.
The PRAC recommended 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. Patients older than 65 years of age should be treated with Xeljanz only when there is no other appropriate treatment.
These recommendations follow the PRAC’s review of an ongoing study in patients with rheumatoid arthritis and an increased risk of cardiovascular disease. The study showed an increased risk of blood clots in deep veins and in the lungs with both the 5 mg and 10 mg twice daily doses of Xeljanz as compared with patients taking TNF-inhibitors (medicines that help reduce inflammation).
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