Posted by Michael Wonder on 01 Sep 2021
FDA requires warnings about increased risk of serious heart related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions
1 September 2021 - Based on a completed U.S. FDA review of a large randomised safety clinical trial, we have concluded there is an increased risk of serious heart related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib citrate).
We are requiring new and updated warnings for two other arthritis medicines in the same drug class as Xeljanz, called Janus kinase (JAK) inhibitors, Olumiant (baricitinib) and Rinvoq (upadacitinib monohydrate).
