FDA Updates Drug Safety Communication for Tofacitinib (Xeljanz, Xeljanz XR)

Published: 07/29/2019

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR), which is used in patients with ulcerative colitis. In addition, the approved use of tofacitinib for ulcerative colitis will be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines. FDA approved these changes, including adding the age

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