血栓症の有害事象とJAK阻害薬に関するFDAへの市販後自発報告の分析
Drug Saf 2018 Apr; 41(4):357–61 DOI: 10.1007/s40264-017-0622-2
Thromboembolic-related adverse events (AEs) were, in general, not considered a class-wide safety concern after analysis of tofacitinib (TOF) and ruxolitinib (RUX) clinical data, though pulmonary thrombosis is considered a potential class-wide safety issue and portal vein thrombosis was considered a potential safety issue for RUX. During analysis of baricitinib (BARI) clinical trial data, the FDA expressed concerns regarding thromboembolic events. Following this, the CHMP have recently added a pr...