title: Flutamide-induced hepatotoxicity: report of a case series.
abstract: OBJECTIVE
  To evaluate the characteristics of flutamide induced hepatotoxicity.
  
  
  METHODS
  In this retrospective study we have analyzed all cases of flutamide hepatotoxicity submitted to the Andalucian Registry of drug-induced liver disease. Data were collected using a structured reporting form. Causality assessment was performed using two clinical scales: the standard CIOMS scale and the recently developed María and Victorino scale.
  
  
  RESULTS
  Nine of 185 patients (4.9%) were identified. In 8 male patients, mean age 75 years (range 65-83), flutamide was indicated for palliative therapy of disseminated prostatic carcinoma, and in one young female (14 years) was given for the treatment of facial hirsutism. The mean duration of the flutamide therapy was 151 days (range 4-443). All patients presented with overt liver injury, the most frequent features being asthenia, anorexia, weight loss, nausea, vomiting and jaundice. No patient showed hypersensitivity features. In two patients (22%) the hepatic damage evolved to fulminant liver failure, one of them undergoing a liver transplantation and the other subsequently died. An additional patient died of a non-hepatic related cause when his liver function was improving. Causality assessment by the two clinical scales did not exclude any case, but the two patients who died where classified as unlikely by the María and Victorino scale.
  
  
  CONCLUSIONS
  Flutamide can induce severe acute hepatitis, probably due to an idiosyncratic metabolic mechanism. Liver tests monitoring should probably be mandatory during the first months of flutamide therapy and the drug withdrawn if transaminases began to increase.
authors.affiliation: Unit of Hepatology, Digestive and Clinical Pharmacology Services, University Hospital Virgen de la Victoria, Málaga, Spain.
authors.forename: M
authors.initials: M
authors.lastname: García Cortés
authors.forename: R J
authors.initials: RJ
authors.lastname: Andrade
authors.forename: M I
authors.initials: MI
authors.lastname: Lucena
authors.forename: H
authors.initials: H
authors.lastname: Sánchez Martínez
authors.forename: M C
authors.initials: MC
authors.lastname: Fernández
authors.forename: T
authors.initials: T
authors.lastname: Ferrer
authors.forename: R
authors.initials: R
authors.lastname: Martín-Vivaldi
authors.forename: G
authors.initials: G
authors.lastname: Peláez
authors.forename: F
authors.initials: F
authors.lastname: Suárez
authors.forename: M
authors.initials: M
authors.lastname: Romero-Gómez
authors.forename: J L
authors.initials: JL
authors.lastname: Montero
authors.forename: E
authors.initials: E
authors.lastname: Fraga
authors.forename: R
authors.initials: R
authors.lastname: Camargo
authors.forename: R
authors.initials: R
authors.lastname: Alcántara
authors.forename: M A
authors.initials: MA
authors.lastname: Pizarro
authors.forename: E
authors.initials: E
authors.lastname: García-Ruiz
authors.forename: M
authors.initials: M
authors.lastname: Rosemary-Gómez
mesh_terms: D000293:Adolescent; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury; D005260:Female; D005485:Flutamide / Q000009:adverse effects*; D006628:Hirsutism / Q000188:drug therapy; D006801:Humans; D008099:Liver / Q000187:drug effects*; D008297:Male; D011471:Prostatic Neoplasms / Q000188:drug therapy; D012189:Retrospective Studies
chemical_list: D018931:Antineoplastic Agents, Hormonal; D005485:Flutamide