OBJECTIVE: Valproic acid is often used in psychiatry to treat schizophrenia and other conditions outside of indication ("off-label"). However, its effectiveness has not been sufficiently demonstrated and its use is not exempt of adverse effects. This study's main objective is to determine the frequency of use of valproic acid in approved indications and the "off-label" use in psychiatric patients. METHODS: A cross-sectional study on July 7, 2014 with a sample of 167 patients residents in a psychiatric center was designed. Demographics, valproic acid treatment, posology and associated drug treatment, monitoring safety parameters, interactions and valproic acid concentrations. RESULTS: Valproic acid is prescribed in 1 of 3 patients of the center. It was used in the approved indications in 8 (15%) of the 53 patients analyzed: 5 (9%) of them with bipolar disorder and 3 (6%) diagnosed with epilepsy. Other 5 patients (9%) were included in the extended schizoaffective disorder indication. 76% (40) of the evaluated patients were prescribed valproic acid off-label. The mean dose of valproic acid was 1.26 Defined Daily Dose / patient / day. An average of 6 drugs associated with valproic acid was found. 18% of patients had thrombocytopenia. CONCLUSIONS: Valproic acid is often used off-label in psychiatric patients. It should be assessed the benefit-risk in this population. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.
OBJECTIVE:Valproic acid is often used in psychiatry to treat schizophrenia and other conditions outside of indication ("off-label"). However, its effectiveness has not been sufficiently demonstrated and its use is not exempt of adverse effects. This study's main objective is to determine the frequency of use of valproic acid in approved indications and the "off-label" use in psychiatricpatients. METHODS: A cross-sectional study on July 7, 2014 with a sample of 167 patients residents in a psychiatric center was designed. Demographics, valproic acid treatment, posology and associated drug treatment, monitoring safety parameters, interactions and valproic acid concentrations. RESULTS:Valproic acid is prescribed in 1 of 3 patients of the center. It was used in the approved indications in 8 (15%) of the 53 patients analyzed: 5 (9%) of them with bipolar disorder and 3 (6%) diagnosed with epilepsy. Other 5 patients (9%) were included in the extended schizoaffective disorder indication. 76% (40) of the evaluated patients were prescribed valproic acid off-label. The mean dose of valproic acid was 1.26 Defined Daily Dose / patient / day. An average of 6 drugs associated with valproic acid was found. 18% of patients had thrombocytopenia. CONCLUSIONS:Valproic acid is often used off-label in psychiatricpatients. It should be assessed the benefit-risk in this population. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.