Today, Sept.1st, the FDA announced its decision regarding tofacitinib's safety concerns from the Oral Surveillance study - handing down warnings for not only Pfizer's JAK inhibitor, but also for other marketed JAK inhibitors from AbbVie and Eli Lilly & Co.
These safety concerns arise from the Oral Surveillance study - a large, post-marketing, safety trial of tofacitinib versus adalimumab in high risk patients. New warnings about the risks of cardiac events, death and cancer will appear as a revision to the "boxed warnings" in the product label (package insert) for all JAK inhibitors - tofacitinib, baricitinib and upadacitinib.