May 19 2022

Classification of the active ingredient valproic acid

Risk level in pregnancy: This medicine is classified as Category D.

Valproic acid can cause decreased fetal growth and congenital malformations, which may happen very early, including neural tube defects (1-2%), facial abnormalities or in the members, hyperbilirubinemia, hepatotoxicity (which may be fatal), transient hyperglycinemia , afibrinogenaemia and withdrawal syndrome (fetal or neonatal).

This drug, therefore, cannot be given to a woman of childbearing age, unless it is essential to treat their disease, especially in disorders that may be associated with risk of death or permanent injury, such as migraine.

Women must use effective contraceptive methods during treatment with valproic acid. Those who are planning a pregnancy should be counseled about the risks associated with treatment and the benefits of using this medicine during pregnancy, as well as therapeutic alternatives available.

Valproic acid should not be stopped suddenly, because it may precipitate seizures with hypoxia and threat to life of the mother and fetus.

It is not known whether the risk of neural tube defects or intrauterine growth reduction in offspring of women receiving valproate can be reduced by folic acid administration, although this substance should be recommended during pregnancy or outside it in patients taking acid valproic.

Update 18.07.2009

Meaning of category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.