BRIEF—FDA Xeljanz drug safety communication

The US Food and Drug Administration has approved new warnings about an increased risk of blood clots and of death with the 10mg twice daily dose of Xeljanz, Xeljanz XR (tofacitinib), which is used in patients with ulcerative colitis.

Xeljanz is an important drug for US pharma giant Pfizer, bringing in revenues of $1.77 billion in 2018.The European Medicines Agency has also issued warnings on the safety of this drug.

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. The FDA approved these changes, including adding its most prominent Boxed Warning, after reviewing interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis (RA) that examined a lower and this higher dose of the medicine.