Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine

FDA is warning patients and health care providers that preliminary results from a safety clinical trial found an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR—Pfizer) compared with tumor necrosis factor (TNF) inhibitors. The safety trial, required by FDA, also investigated other potential risks, including blood clots in the lungs and death. Those final results are not yet available. The agency warned in 2019 that interim trial results showed a higher risk of blood clots and death with the higher 10 mg twice daily dosage, and it approved a boxed warning to the tofacitinib prescribing information. The clinical trial is now over, and initial results indicate a higher occurrence of serious heart-related events and cancer in rheumatoid arthritis patients treated with both doses of tofacitinib compared with patients treated with a TNF inhibitor. FDA is waiting for further results from the study. FDA recommends that health care professionals consider the benefits and risks of tofacitinib when deciding whether to prescribe or continue patients on the medicine. Physicians should continue to follow the recommendations in the tofacitinib prescribing information. Patients should not stop taking tofacitinib without first consulting with their health care professionals, as doing so may worsen their condition.