- For the second time in 6 months, the FDA has issued warnings about increased risk for thrombosis, sometimes fatal, with a 10-mg, twice-daily dose of tofacitinib (Xeljanz, Xeljanz XR) used for ulcerative colitis.
- The previous warning about clots was issued in February 2019.
- The newest warning, similar to the earlier one, comes from an ongoing safety clinical trial of tofacitinib use in rheumatoid arthritis.
Why this matters
- Although the details of the safety trial were not disclosed, the FDA is making 3 changes to the labeling for tofacitinib:
- Enhancing its black box warning about the higher risk of thrombosis.
- Limiting the approved use of tofacitinib in ulcerative colitis to patients who are not treated effectively or are intolerant to TNF blockers.
- Strengthening the Warnings and Precautions section.
- The FDA advises patients to tell their providers if they have a history of blood clots or heart problems and to stop taking tofacitinib and seek emergency attention if they have unusual symptoms indicative of blood clots.
- The FDA advises healthcare professionals to:
- Discontinue tofacitinib in patients with thrombosis.
- Reserve tofacitinib for patients with ulcerative colitis who have failed or are intolerant to TNF blockers.
- Avoid tofacitinib in patients with elevated thrombosis risk.
- Report adverse events to the FDA's MedWatch Program.