Serious Liver Injury Associated with Macitentan: A Case Report.
|アブストラクト||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.|
|投稿者||Tran, Thao T; Brinker, Allen D; Munoz, Monica|
|組織名||Division of Pharmacovigilance I, US Food and Drug Administration, Silver Spring,;Maryland.|