FDA to Require Additional Warnings for JAK Inhibitors Treating Select Chronic Inflammatory Conditions

In a Sept. 1, 2021 announcement, FDA concluded that the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib) increased the risk of serious heart-related events (such as heart attack and stroke), cancer, blood clots, and death, which was based on a review of a large, randomized safety clinical trial.

The trial compared Xeljanz with tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis. The results showed an increased risk of blood clots and death with the lower dose of Xeljanz.

The FDA announcement states that the agency will require new and updated warnings for two Janus kinase (JAK) inhibitors, Olumiant (baricitinib) and Rinvoq (upadacitinib), which are in the same drug class as Xeljanz. These drugs have not been studied in trials like Xeljanz in the safety clinical trial. However, since they share mechanisms of action with Xeljanz, Olumiant and Rinvoq may have similar risks as seen in the Xeljanz safety trial.