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.
As a condition of its approval, Pfizer was required to conduct a postmarketing safety trial in patients with rheumatoid arthritis (RA) who were taking methotrexate to evaluate the risk for serious CV events, malignancies and infections. In contrast to previous