Study Shows Arthritis Drug Xeljanz Poses Risk of Heart Problems, Cancer, FDA Warns

WASHINGTON, D.C. — The Food and Drug Administration says preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis drugs Xeljanz and Xeljanz XR (tofacitinib) compared to tumor necrosis factor (TNF) inhibitors.

In a Feb. 4 alert, the FDA explained that it required the safety trial, which also investigated other potential risks posed by tofacitinib, including blood clots in the lungs and death. The agency says those final results are not yet available.

In February and July 2019, the FDA approved a Boxed Warning to …