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FEBRUARY 5, 2021

FDA Warns of Possible Serious CV Events, Cancer Linked to Xeljanz

By Marie Rosenthal

The FDA issued an alert concerning an increased risk for serious cardiovascular (CV) events and malignancies with the Janus kinase inhibitor, tofacitinib (Xeljanz, Pfizer), compared with tumor necrosis factor (TNF) inhibitors. 

Tofacitinib was first approved in 2012 to treat adults with rheumatoid arthritis (RA) who did not respond well to methotrexate. Since then, it has been granted indications for psoriatic arthritis and ulcerative colitis. Tofacitinib works by