PMID- 29286546
OWN - NLM
STAT- MEDLINE
DCOM- 20181231
LR  - 20181231
IS  - 1875-9114 (Electronic)
IS  - 0277-0008 (Linking)
VI  - 38
IP  - 2
DP  - 2018 Feb
TI  - Serious Liver Injury Associated with Macitentan: A Case Report.
PG  - e22-e24
LID - 10.1002/phar.2078 [doi]
AB  - 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.
CI  - Published 2017. This article is a U.S. Government work and is in the public 
      domain in the USA.
FAU - Tran, Thao T
AU  - Tran TT
AUID- ORCID: 0000-0002-9878-5031
AD  - Division of Pharmacovigilance I, US Food and Drug Administration, Silver Spring, 
      Maryland.
FAU - Brinker, Allen D
AU  - Brinker AD
AD  - Division of Pharmacovigilance I, US Food and Drug Administration, Silver Spring, 
      Maryland.
FAU - Munoz, Monica
AU  - Munoz M
AD  - Division of Pharmacovigilance I, US Food and Drug Administration, Silver Spring, 
      Maryland.
LA  - eng
PT  - Case Reports
PT  - Journal Article
DEP - 20180130
PL  - United States
TA  - Pharmacotherapy
JT  - Pharmacotherapy
JID - 8111305
RN  - 0 (Endothelin A Receptor Antagonists)
RN  - 0 (Endothelin B Receptor Antagonists)
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfonamides)
RN  - Z9K9Y9WMVL (macitentan)
SB  - IM
MH  - Chemical and Drug Induced Liver Injury/blood/*diagnosis
MH  - Endothelin A Receptor Antagonists/*adverse effects/blood
MH  - Endothelin B Receptor Antagonists/*adverse effects/blood
MH  - Female
MH  - Humans
MH  - Pyrimidines/*adverse effects/blood
MH  - Sulfonamides/*adverse effects/blood
MH  - Young Adult
OTO - NOTNLM
OT  - drug safety
OT  - patient safety
OT  - pharmacy education
OT  - pharmacy practice
OT  - public health
EDAT- 2017/12/30 06:00
MHDA- 2019/01/01 06:00
CRDT- 2017/12/30 06:00
PHST- 2017/12/30 06:00 [pubmed]
PHST- 2019/01/01 06:00 [medline]
PHST- 2017/12/30 06:00 [entrez]
AID - 10.1002/phar.2078 [doi]
PST - ppublish
SO  - Pharmacotherapy. 2018 Feb;38(2):e22-e24. doi: 10.1002/phar.2078. Epub 2018 Jan 
      30.