6533b874fe1ef96bd12d63df
RESEARCH PRODUCT
Non-fatal and fatal liver failure associated with valproic acid.
Ferdinand KellerMarkus SchmidCarlos Schönfeldt-lecuonaRoland W. FreudenmannChristoph HiemkeBernhard J. ConnemannM FuchsMaximilian GahrW. Kratzersubject
AdultMalemedicine.medical_specialtyFatal outcomeAdolescentGastroenterologyBenzodiazepinesPharmacovigilancePharmacotherapyInternal medicineGermanyPharmacovigilancemedicineHumansPharmacology (medical)ChildAgedAged 80 and overValproic Acidbusiness.industryValproic AcidLiver failureInfantGeneral MedicineMiddle AgedPsychiatry and Mental healthAnesthesiaConcomitantChild Preschoollipids (amino acids peptides and proteins)AnticonvulsantsDrug Therapy CombinationFemaleChemical and Drug Induced Liver Injurybusinessmedicine.drugdescription
Little is known about hepatotoxicity associated with valproic acid (VPA), a widely used substance in neuropsychiatry.All reported cases to the German Federal Institute for Drugs and Medical Devices between 1993 and 2009 of VPA-induced serious hepatic side effects were evaluated.A total of 132 cases of serious VPA-associated liver failure were identified. Approximately one third (34.8%) occurred under VPA monotherapy, while the majority was seen with VPA plus co-medication, most frequently antiepileptics (34.8%) and benzodiazepines (16.7%). A subgroup of 34 cases (25.8%) had a fatal outcome, the largest number reported to date. Of these, 32.4% were under VPA monotherapy and 67.6% under VPA plus concomitant medication. Within the study period a significant increase in the total number of reported cases and the subgroup of fatal cases was found.This first pharmacovigilance study of VPA-associated liver failure indicates a higher rate of non-fatal and fatal liver failure when VPA is given with co-medication as compared to monotherapy. However, co-medication per se does not increase the risk of fatalities.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2012-08-22 | Pharmacopsychiatry |