The FDA is requiring revisions to the boxed warning for the arthritis and ulcerative colitis medicine tofacitinib (Xeljanz/Xeljanz XR), as well as two other Janus kinase inhibitors that treat arthritis, baricitinib (Olumiant) and upadacitinib (Rinvoq), to include information about the risks of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death, the agency announced on Sept. 1.
The change is based on an FDA review of a large randomized safety clinical trial of tofacitinib, which found an increased risk of such adverse events. Baricitinib and upadacitinib have not been studied in similar large safety trials, so the risks have not been adequately evaluated; however, since they share mechanisms of action with tofacitinib, the FDA considered that these medicines may be associated with similar risks.
Two other Janus kinase inhibitors, ruxolitinib (Jakafi) and fedratinib (Inrebic), are not indicated for the treatment of arthritis and other inflammatory conditions and so are not part of the updates being required to the prescribing information for tofacitinib, baricitinib, and upadacitinib. Ruxolitinib and fedratinib are used to treat blood disorders and require different updates to their prescribing information, the FDA said.