Ulcerative Colitis

FDA Issues Safety Alert for a JAK Inhibitor

The US Food and Drug Administration (FDA) has issued a safety alert for twice-daily tofacitinib (Xeljanz), 10 mg, for the treatment of ulcerative colitis (UC). Interim data from an ongoing safety clinical trial involving individuals with rheumatoid arthritis indicated an increased risk of blood clots and death.

Further, the FDA limited the approved use of tofacitinib to certain individuals who are not treated effectively or who experience severe adverse effects with certain other medications.

It is recommended that tofacitinib be used for the treatment of UC among individuals who have failed or do not tolerate tumor necrosis factor blockers. The medication should be administered at the lowest effective dose, and the twice-daily, 10 mg, dose should be limited to the shortest duration needed.

Tofacitinib use should be avoided among those who may be at increased risk of thrombosis. 

“Health care professionals should discontinue tofacitinib and promptly evaluate patients with symptoms of thrombosis. Counsel patients about the risks and advise them to seek medical attention immediately if they experience any unusual symptoms.”


FDA. Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Due to an Increased Risk of Blood Clots and Death with Higher Dose. Published July 26, 2019. Accessed July 26, 2019.