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SEPTEMBER 3, 2021

FDA Warns of Serious Risks, Including Death, With Tofacitinib

Originally published by our sister publication, Gastroenterology Endoscopy News

By David Wild

The FDA is requiring the addition of warnings about increased risks for cancer, serious cardiovascular events and death to the labeling of three Janus kinase (JAK) inhibitors: tofacitinib (Xeljanz/Xeljanz XR, Pfizer), which is approved for ulcerative colitis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis and rheumatoid arthritis (RA), and baricitinib (Olumiant, Lilly) and upadacitinib