Black box warns of increased risk of blood clots and death.
The FDA approved new warnings of increased risk of blood clots and death for the 10-mg twice-daily dose of Xeljanz and Xeljanz XR (tofacitinib). For treatment of ulcerative colitis, tofacitinib has been limited to patients who are not treated effectively or who experience severe side effects from other medications.
An interim analysis of a trial studying the 5-mg twice-daily dosage of tofacitinib approved for patients with rheumatoid arthritis the 10-mg twice-daily dosage showed an increased occurrence of blood clots and death in patients treated with the 10-mg tofacitinib dosage when compared to the 5-mg dosage and similar tumor necrosis factor (TNF) blocker.
Healthcare professionals should discontinue tofacitinib and promptly evaluate patients experience symptoms of thrombosis, including:
Other FDA recommendations for healthcare professionals include