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 (Rinvoq, AbbVie), indicated for RA only.
In a Drug Safety Communication (DSC) issued on Sept.