[FDA Drug Safety Communication, February 4, 2021] – The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Tofacitinib (Xeljanz) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available.
In February 2019 and July 2019, FDA warned that interim trial results showed an increased risk of blood clots and death with the higher 10 mg twice daily dosage, and as a result, approved a Boxed Warning to the tofacitinib prescribing information. The clinical trial is now complete and initial results show a higher occurrence of serious heart-related events and cancer in rheumatoid arthritis (RA) patients treated with both doses of tofacitinib compared to patients treated with a TNF inhibitor. FDA is awaiting additional results from the trial.
Tofacitinib works by decreasing the activity of the immune system; an overactive immune system contributes to rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ulcerative colitis. It was first approved in 2012 to treat adults with RA who did not respond well to methotrexate. In 2017, FDA approved tofacitinib to treat patients with PsA who did not respond well to methotrexate or other similar medicines. In 2018, FDA approved the medicine to treat ulcerative colitis, a chronic inflammatory disease affecting the colon.
FDA is recommending that health care professionals should consider the benefits and risks of tofacitinib when deciding whether to prescribe or continue patients on the medicine.
Source: