The Food and Drug Administration is requiring a warning label on the arthritis and ulcerative colitis drugs Xeljanz and Xeljanz XR (tofacitinib) and two other drugs in this class, citing an increased risk of adverse heart-related events.
The move follows the agency’s review of a large clinical safety trial linking lower doses of Xeljanz and Xeljanz XR with heart attack or stroke, cancer, blood clots and death. Prior trial results had found these risks only at higher doses, the agency disclosed on Wednesday.
Although they were not involved in the trials, two other drugs in the Janus kinase (JAK) inhibitors class, Olumiant (baricitinib) and Rinvoq (upadacitinib), are included in the warning requirement. They share similar mechanisms of action, and may share similar risks, the agency explained in its announcement.
FDA will watch for any safety updates regarding two additional JAK inhibitors, Jakafi (ruxolitinib) and Inrebic (fedratinib), the agency added. These are not used to treat arthritis or other inflammatory conditions “and so are not a part of the updates being required to the prescribing information for Xeljanz, Xeljanz XR, Olumiant, and Rinvoq,” it said.
Jakafi and Inrebic are used to treat blood disorders and require different updates to their prescribing information, FDA noted.