FDA Says Twice-Daily Use of Xeljanz Can Cause Blood Clots, Death

WASHINGTON, D.C. — The Food and Drug Administration has approved new warnings concerning an increased risk of blood clots and death associated with twice-daily 10 mg doses of Pfizer’s rheumatoid arthritis drugs Xeljanz and Xeljanz XR (tofacitinib) in patients with ulcerative colitis.

According to the July 26 Drug Safety Communication, the approved use of tofacitnib for ulcerative colitis “will be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines.”

“We approved these changes, including adding our most prominent Boxed Warning, after reviewing interim data from an ongoing safety clinical trial …