FDA Says Higher Dose of Tofacitinib (Xeljanz) Can Cause Blood Clots, Death

WASHINGTON, D.C. — The Food and Drug Administration says a safety clinical trial has revealed an increased risk of blood clots in the lungs and death in patients with rheumatoid arthritis when a twice-daily 10 mg dose of tofacitinib (Xeljanz, Xeljanz XR) was used.

In a Feb. 25 alert, the agency clarified that it has not approved the 10 mg twice daily dose for patients with RA. Rather, the dose is only approved for patients with ulcerative colitis.

Tofacitinib was approved for treatment of moderate to severe rheumatoid arthritis that responds inadequately to methotrexate or in those who are intolerant …