title: The incidence and clinical characteristics of symptomatic propylthiouracil-induced hepatic injury in patients with hyperthyroidism: a single-center retrospective study.
abstract: OBJECTIVE
  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few months of PTU administration with rare frequency, but its clinical course is relatively benign once the drug is withdrawn.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.
authors.affiliation: Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.
authors.forename: H J
authors.initials: HJ
authors.lastname: Kim
authors.forename: B H
authors.initials: BH
authors.lastname: Kim
authors.forename: Y S
authors.initials: YS
authors.lastname: Han
authors.forename: I
authors.initials: I
authors.lastname: Yang
authors.forename: K J
authors.initials: KJ
authors.lastname: Kim
authors.forename: S H
authors.initials: SH
authors.lastname: Dong
authors.forename: H J
authors.initials: HJ
authors.lastname: Kim
authors.forename: Y W
authors.initials: YW
authors.lastname: Chang
authors.forename: J I
authors.initials: JI
authors.lastname: Lee
authors.forename: R
authors.initials: R
authors.lastname: Chang
mesh_terms: D000328:Adult; D017677:Age Distribution; D000368:Aged; D013956:Antithyroid Agents / Q000009:adverse effects* / Q000627:therapeutic use; D056486:Chemical and Drug Induced Liver Injury; D005260:Female; D006801:Humans; D006980:Hyperthyroidism / Q000175:diagnosis / Q000188:drug therapy*; D015994:Incidence; D007723:Korea / Q000453:epidemiology; D008099:Liver / Q000187:drug effects* / Q000293:injuries; D008107:Liver Diseases / Q000453:epidemiology*; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011336:Probability; D011441:Propylthiouracil / Q000009:adverse effects* / Q000627:therapeutic use; D012189:Retrospective Studies; D012307:Risk Factors; D017678:Sex Distribution
chemical_list: D013956:Antithyroid Agents; D011441:Propylthiouracil