How is sodium valproate teratogenic?
It is believed that VPA crosses the placenta and interferes with normal development causing developmental abnormalities in the fetus (teratogenesis). If a woman with epilepsy wishes to have children, the recommended treatment is to avoid VPA and use a single drug or a newer antiepileptic medication.
How does sodium valproate affect pregnancy?
When sodium valproate is taken during pregnancy, it can affect how the baby develops in the womb and cause ‘birth defects’, including: ‘minor malformations’ (such as small fingers and toes) and. ‘major malformations’ (such as spina bifida or a cleft palate, which may need surgery to correct them)
Is it safe to take sodium valproate during pregnancy?
Sodium valproate is not recommended in pregnancy, as it can cause birth defects and problems with your baby’s learning and behaviour. If there’s a chance you could become pregnant while taking this medicine, your doctor will put you on Prevent, the valproate pregnancy prevention programme.
Is Epival safe in pregnancy?
Valproate medicines include sodium valproate (Epilim, Episenta, Epival, Depakote) and valproic acid (Convulex). Taking valproate medicine during pregnancy can cause birth defects and problems with a child’s development and learning.
Why is sodium valproate contraindicated pregnancy?
The use of Sodium valproate (Epilim) is contraindicated in pregnancy due to the risk to the unborn baby (fetus). Congenital malformations have been estimated to affect between 6.7%1 and 12.4%2 of children exposed to Epilim in the womb. The rate of malformations in the general population is 2-3%.
What are the pregnancy precautions for valproate?
Dietary folic acid supplementation should be routinely recommended both prior to conception and during pregnancy for patients taking valproate because studies in the general population show that folic acid supplementation prior to conception and during early pregnancy reduces the risk of neural tube defects.
Is valproic acid contraindicated in pregnancy?
FDA is advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches.
Does sodium valproate cause miscarriage?
Can taking sodium valproate in pregnancy cause miscarriage? One small study has shown that women who took daily sodium valproate doses of 750mg or more were about three times more likely to have a miscarriage than women not receiving epilepsy treatments during pregnancy.
Despite significant teratogenic risks, sodium valproate is still widely prescribed in many countries to women of childbearing age, as a mood stabiliser in bipolar disorder and also in epilepsy. The UK has recently banned valproate use in women who are not in a pregnancy prevention programme.
Is there a teratogenic effect of sodium valproate?
The teratogenicity of the widely popular antiepileptic drug (AED) and mood stabiliser sodium valproate (also known as valproate, VPA) has been evidenced by previous research; however, these findings have often been limited by a small population sample of exposed women and a retrospective study design.
Can a child be exposed to valproate in utero?
Several published epidemiological studies have indicated that children exposed to valproate in utero have lower cognitive test scores than children exposed to either another antiepileptic drug in utero or to no antiepileptic drugs in utero.
Is the FDA aware of the risks of valproate?
FDA has evaluated all available evidence to date, and will be adding information about the risk of lower cognitive test scores to the valproate product labels in the Warnings and Precautions section, the Use in Specific Populations: Pregnancy section, and to the Medication Guides that are being developed for the valproate drug products.