New Warnings for Tofacitinib Issued by FDA

July 29, 2019

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:

  • Sudden shortness of breath

  • Chest pain that worsens with breathing

  • Swelling of a leg or arm

  • Leg pain or tenderness, along with red or discolored skin 

 

Other FDA recommendations for healthcare professionals include

  • Counseling patients about the risks of tofacitinib and advising them to seek medical attention should any of the aforementioned symptoms arise

  • Reserve tofacitinib to treat ulcerative colitis in patients who have failed or do not tolerate TNF blockers

  • Avoid tofacitinib in patients who may have a higher risk of thrombosis 

 

Full Prescribing Information