FDA Requires Warning That JAK Inhibitors May Cause Serious Side Effects

The FDA has called for a revised Boxed Warning stating that Pfizer’s JAK inhibitors Xeljanz and Xeljanz XR (tofacitinib) ― used to treat arthritis and ulcerative colitis ― can cause an increased risk of serious heart-related events, cancer, blood clots and death.

The agency is also requiring updated warnings for two arthritis drugs belonging to the same class as Xeljanz: Eli Lilly’s and Incyte’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib).

“Olumiant and Rinvoq have not been studied in trials similar to the large safety clinical trial with Xeljanz, so the risks have not been adequately evaluated,” the FDA said. “However, since they share mechanisms of action with Xeljanz, [the] FDA considers that these medicines may have similar risks as seen in the Xeljanz safety trial.”