Use in Pregnancy: Risk Associated with Epilepsy and Antiepileptics: In offsprings born to mothers with epilepsy receiving any epileptic treatment, the global rate of malformations has been demonstrated to be 2-3 times higher than the rate (approximately 3%) reported in formation. Although an increased number of children with malformations has been reported in case of multiple drug therapy, the respective part of treatments and disease has not been formally established. Malformations most frequently encountered are labial clefts and cardiovascular malformations.
Sudden discontinuation in the antiepileptic therapy may be associated with a worsening of the disease in the mother and subsequent untoward effects in the foetus.
Risk Associated with Sodium Valproate: In animals: Teratogenic effects have been demonstrated in the mouse, rat and rabbit.
In humans: The global risk of malformations in women receiving valproate during the 1st trimester of pregnancy is not higher than the risk described with other antiepileptics. A few cases of multiple malformations and facial dysmorphia have been reported. The frequency of those effects has not yet been clearly established. Nevertheless sodium valproate preferably induces neutral tube defects: Myelomeningocele, spina bifida and malformations of which antenatal diagnosis is possible. The frequency of this effect is estimated to be 1-2%.
In view of the aforementioned; should a woman expect to become pregnant, review the indication for antiepileptic therapy; folate supplementation may be considered.
During pregnancy, valproate antiepileptic treatment should not be discontinued if it has been effective.
Monotherapy is to be recommended; the minimum effective daily dosage should be used, in several divided doses over the day. Nevertheless, specialized antenatal monitoring should be instituted in order to detect the possible occurrence of neutral tube effect.
Use in Lactation: Excretion of valproate in breast milk is low, with a concentration between 1-10% of maternal serum levels: Up to now, breastfed children that have been monitored during the neonatal period have not experienced clinical effects.