title: Hepatotoxicity associated with the new antidepressants.
abstract: BACKGROUND
  Safety profiles of classical and new antidepressants are well established. Hepatotoxicity is known to occur. Recently, several cases of severe hepatic injury associated with the new antidepressants have been reported, prompting us to quantify this risk.
  
  
  METHODS
  To estimate the cumulative incidence of hepatic adverse reactions associated with antidepressants, we used cases of hepatic damage collected via spontaneous reporting and included in the Spanish Pharmacovigilance System database; for exposure, we have used data from drug sales to the Spanish National Health System.
  
  
  RESULTS
  The estimated reported incidence did not show major differences for the antidepressants studied, ranging from 1.28 cases per 100,000 patient-years for sertraline to 4.00 for clomipramine, except for nefazodone, which was the agent that had the highest incidence with 28.96 cases per 100,000 patient-years.
  
  
  CONCLUSIONS
  The reported incidence of hepatic adverse reactions to nefazodone seems to be higher than that estimated so far. Given the high prevalence of depression and the widespread use of antidepressants, physicians should be alert to the possibility that these medications cause hepatitis and consider early discontinuation of an antidepressant if the condition is suspected.
authors.affiliation: Instituto de Farmacoepidemiología de la Universidad de Valladolid, Spain. carvajal@ife.uva.es
authors.forename: Alfonso
authors.initials: A
authors.lastname: Carvajal García-Pando
authors.forename: Javier
authors.initials: J
authors.lastname: García del Pozo
authors.forename: Ana Sánchez
authors.initials: AS
authors.lastname: Sánchez
authors.forename: Martín Alfonso
authors.initials: MA
authors.lastname: Velasco
authors.forename: Ana María
authors.initials: AM
authors.lastname: Rueda de Castro
authors.forename: M Isabel
authors.initials: MI
authors.lastname: Lucena
mesh_terms: D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D056486:Chemical and Drug Induced Liver Injury / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D003866:Depressive Disorder / Q000188:drug therapy*; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D015994:Incidence; D008107:Liver Diseases / Q000175:diagnosis / Q000453:epidemiology; D010879:Piperazines; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D012720:Severity of Illness Index; D014230:Triazoles / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D000928:Antidepressive Agents; D010879:Piperazines; D017367:Selective Serotonin Reuptake Inhibitors; D014230:Triazoles; C051752:nefazodone