FDA Extends Xeljanz Safety Warnings to Other JAK Inhibitors
October 14, 2021
The FDA is requiring revisions about increased risk of serious heart-related events such as heart attack, stroke, cancer, blood clots and death to the labels of the Janus kinase (JAK) inhibitors indicated for inflammatory conditions: Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and AbbVie Inc.’s Rinvoq (upadacitinib). The move follows the agency’s review of a large, randomized safety clinical trial of Xeljanz. The FDA also is limiting the approved uses for all the drugs to certain people who have not responded to or cannot tolerate at least one tumor necrosis factor (TNF) inhibitor. While some payers may already have had TNF inhibitors as a first step, they need to make sure that they have utilization management strategies in place to help ensure these drugs are used in the second-line setting, recommend industry experts.
The trial compared Xeljanz with TNFs in people with rheumatoid arthritis (RA) and showed an increased risk of blood clots and death with a lower dose of Xeljanz. A prior study whose results Pfizer disclosed on Jan. 27, 2021, showed the same results but at a higher dose.