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Serious Liver Injury Associated with Macitentan: A Case Report
Thao T Tran1, Allen D Brinker1, Monica Muñoz1
1Division of Pharmacovigilance I, US Food and Drug Administration, Silver Spring, Maryland.
Pharmacotherapy
|December 30, 2017
Summary
Endothelin receptor antagonists (ERAs) like bosentan can cause liver injury. A recent report details the first case of severe liver damage, fulminant hepatitis, linked to the ERA macitentan in a pulmonary arterial hypertension patient.
Area of Science:
- Hepatology
- Pharmacology
- Pulmonology
Background:
- Endothelin receptor antagonists (ERAs) are used to treat pulmonary arterial hypertension (PAH).
- Previous ERAs, such as bosentan and sitaxentan, have been associated with significant liver injury.
- The safety profile of macitentan regarding hepatotoxicity requires further investigation.
Observation:
- A case report identified a 23-year-old patient with idiopathic PAH (NYHA class III).
- The patient was treated with the ERA macitentan.
- Liver transplantation was performed 13 months after initiating macitentan therapy.
Findings:
- This report describes the first instance of fulminant hepatitis associated with macitentan use.
- The adverse event was identified through the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).
- The patient experienced severe liver injury necessitating a liver transplant.
Implications:
- Macitentan, like other ERAs, may pose a risk of severe hepatotoxicity.
- Clinicians should monitor patients on macitentan for signs of liver injury.
- Further pharmacovigilance is crucial to fully understand the liver safety of macitentan.
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