The FDA has issued new warnings about an increased risk for blood clots and death associated with the 10-mg twice-daily dose of tofacitinib (Xeljanz, Xeljanz XR, Pfizer), used by patients with ulcerative colitis, a chronic, inflammatory disease affecting the colon. In addition, the approved use of tofacitinib for ulcerative colitis will be limited to certain patients who are treated ineffectively or who experience severe side effects with certain other medicines.
These changes, including the