FDA warns about blood clots, death with higher-dose tofacitinib

  • FDA

  • Miriam Davis, PhD
  • Clinical Essentials
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Takeaway

  • 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.

Key recommendations

  • 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.