Sign Out
Pregnancy: From experience in treated epileptic mothers, the risk associated with the use of VELTILA during pregnancy has been described as follows: Risk associated with epilepsy and anti-epileptics: In offspring born to mothers with epilepsy receiving any anti-epileptic treatment, the global rate of malformations has been demonstrated to be 2 to 3 times higher than the rate (approximately 3%) reported in the general population. Although an increased number of children with malformations have 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.
Developmental delay has been very rarely reported in children born to mothers with epilepsy. It is not possible to differentiate what may be due to genetic, social, environmental factors, maternal epilepsy or anti-epileptic treatment.
Not withstanding those potential risks, no sudden discontinuation in the anti-epileptic therapy should be undertaken as this may lead to breakthrough seizures, which could have serious consequences for both the mother and the foetus.
Risk associated with sodium valproate: In animals: teratogenic effects have been demonstrated in the mouse, rat and rabbit.
In humans: cases of facial dysmorphia have been reported. A few cases of multiple malformations, particularly of the limbs have been observed. The frequency of those effects has not been yet clearly established. Nevertheless sodium valproate preferably induces neural tube defects (1 to 2%): anencephaly, myelomeningocele and spina bifida.
In view of the previously mentioned data: If a woman plans a pregnancy, it is the opportunity of reviewing the indication for VELTILA therapy. During pregnancy, VELTILA treatment should be reviewed and the risks and benefits should be carefully considered and discussed with the patient. If considered appropriate, folate supplementation should be started before pregnancy and at relevant dosage as it may minimise the risk of neural tube defects. Monotherapy at the minimum effective daily dosage. The administration in several divided doses over the day and the use of a controlled release formulation is preferable.
Specialised prenatal monitoring should be instituted in order to detect the possible occurrence of neural tube defect or another malformation.
Risk in the neonate: Cases of haemorrhagic syndrome have been reported in neonates whose mothers have taken sodium valproate during pregnancy. This haemorrhagic syndrome is related to hypofibrinogenemia; afibrinogenemia has also been reported and may be fatal. Hypofibrinogenemia is possibly associated with decrease of coagulation factors.
Therefore, platelet count, fibrinogen plasma level, coagulation tests and coagulation factors should be investigated in neonates.
Lactation: VELTILA crosses the placenta. When given to breast-feeding mothers, VELTILA is excreted in breast milk. Excretion of valproate in breast milk results in a concentration between 1% and 10% of maternal serum levels.
In bipolar disorders indication, cessation of valproate therapy should be considered.
