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Cited by 99Drug-Induced Hepatotoxicity and ProtectionThyroid Disorders and TreatmentsPharmacovigilance and Adverse Drug Reactions

The incidence and clinical characteristics of symptomatic propylthiouracil-induced hepatic injury in patients with hyperthyroidism: a single-center retrospective study

Kim, Hee-Jin, Kim, Byung-Ho, Han, Yo-Seb, Yang, Inmyung, Kim, Kyeong-Jin, Dong, Seok-Ho, Kim, Hyo-Jong, Chang, Young-Woon +2 more·2001·The American Journal of Gastroenterology
DOI 10.1111/j.1572-0241.2001.03469.x
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Abstract

OBJECTIVES: Although symptomatic propylthiouracil (PTU)-induced hepatic injury is known to be rare, there have been few reports about its exact incidence in patients with hyperthyroidism. We tried to evaluate its incidence in a single center and its clinical course. METHODS: Medical records of 912 hyperthyroid patients who had been diagnosed between March 1990 and December 1998 were reviewed about clinical characteristics, management, and laboratory findings. Symptomatic PTU-induced hepatic injury was defined as the development of jaundice or hepatitis symptoms with at least a 3-times elevation of liver function tests (LFT) without other causes. RESULTS: Four hundred ninety-seven patients (age 42.6 +/- 10.7 yr, male/female 140/357) were included. Clinically overt hepatitis developed in six patients (1.2%; age, 43.7 +/- 14.8 yr; male:female ratio, 3:3) between 12 and 49 days after PTU administration. Jaundice and itching developed in five patients, fever in two, rash in two, and arthralgia in one. Bilirubin, ALT, and ALP increased in five, four, and six patients, respectively (293 +/- 288 micromol/L, 143 +/- 111 U/L, and 265 +/- 81 U/L; normal, < 117 U/L). The type of hepatic injury was cholestatic in three, hepatocellular in one, and mixed in two patients. None resulted from viral hepatitis. There were no statistical differences in age, sex, PTU dose, or T4 and T3 levels at initial diagnosis between patients with and without hepatic injury. LFT normalized in all patients between 16 and 145 (72.8 +/- 46.4) days after the PTU withdrawal. CONCLUSIONS: Symptomatic hepatic injury develops usually within the first few months of PTU administration with rare frequency, but its clinical course is relatively benign once the drug is withdrawn. However, it may be difficult to predict its development, so all patients should be monitored for rise in LFTs at regular intervals, especially during the early period.

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Authors
Kim, H.-J., Kim, B.-H., Han, Y.-S., Yang, I., Kim, K.-J., Dong, S.-H., Kim, H.-J., Chang, Y.-W., Lee, J.-I., & Chang, R.
Affiliations
Kyung Hee University (KR)
ORCID
Venue
The American Journal of Gastroenterology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2001-01
Volume
96
Issue
1
Pages
165-169
ISSN
  • 0002-9270 (ISSN-L)
  • 1572-0241
DOI
10.1111/j.1572-0241.2001.03469.x
OpenAlex
W2057760665
Cited by
99
References
22
Citations by year
2024: 1 · 2023: 2 · 2022: 3 · 2021: 4 · 2020: 5 · 2019: 2 · 2018: 3 · 2017: 2 · 2016: 10 · 2015: 2 · 2014: 7 · 2013: 5 · 2012: 8
FWCI
3.77
Type
journal article
Language
en
Open access
closed
Locations
  • The American Journal of Gastroenterology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords
propylthiouracil, drug-induced liver injury, hyperthyroidism, antithyroid drugs, incidence, jaundice, cholestatic hepatitis, liver function tests, drug withdrawal, adverse drug reactions
MeSH terms
Adult, Aged, Female, Humans, Hyperthyroidism, Korea, Liver, Liver Diseases, Liver Function Tests, Male, Middle Aged, Probability, Propylthiouracil, Retrospective Studies, Risk Factors, Antithyroid Agents, Incidence, Age Distribution, Sex Distribution, Chemical and Drug Induced Liver Injury

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