Division of Pharmacovigilance I, US Food and Drug Administration, Silver Spring, Maryland.
Pharmacotherapy. 2018 Feb;38(2):e22-e24. doi: 10.1002/phar.2078. Epub 2018 Jan 30.
Several endothelin receptor antagonists (ERAs) that were developed for the treatment of pulmonary arterial hypertension (PAH), including bosentan and sitaxentan, have been linked to clinically significant hepatocellular injury, as well as liver failure. We describe the first case of fulminant hepatitis to be reported in association with the ERA macitentan. This case was recently identified within the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) and describes liver transplantation occurring 13 months after macitentan initiation in a young patient (23 years old) with idiopathic PAH New York Heart Association (NYHA) functional class III.
几种用于治疗肺动脉高压（PAH）的内皮素受体拮抗剂（ERAs），包括波生坦和西他生坦，与临床显著的肝细胞损伤以及肝功能衰竭有关。我们描述了首例与 ERA 类药物麦考酚尼相关的暴发性肝炎病例。该病例最近在美国食品和药物管理局不良事件报告系统（FAERS）中被发现，描述了一名年轻的特发性 PAH 纽约心脏协会（NYHA）功能 III 级患者（23 岁）在开始使用麦考酚尼 13 个月后发生肝移植的情况。
