Hepatotoxicity associated with the new antidepressants.
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.
Carvajal García-Pando
Alfonso
A
Instituto de Farmacoepidemiología de la Universidad de Valladolid, Spain. carvajal@ife.uva.es
García del Pozo
Javier
J
Sánchez
Ana Sánchez
AS
Velasco
Martín Alfonso
MA
Rueda de Castro
Ana María
AM
Lucena
M Isabel
MI
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
D000928:Antidepressive Agents; D010879:Piperazines; D017367:Selective Serotonin Reuptake Inhibitors; D014230:Triazoles; C051752:nefazodone