Safe use of medicinal products containing active substance valproate
The U.S. Food and Drug Administration reported an increased risk of birth defects in children whose mothers had been taking valproic acid during the pregnancy. There is an increased risk of neural tube defects and other major birth defects, such as craniofacial defects or cardiovascular malformation in children exposed to valproate-sodium and similar medicinal products (valproic acid and divalproex-sodium) during the pregnancy.
Healthcare professionals should inform women of childbearing potential about these risks and, if possible, consider alternative therapies for such patients.
The prescribing of valproate to women of childbearing potential is justified only in cases when it is essential to manage their medical condition. Those women who are not planning pregnancy should use effective contraception as birth defect risks are particularly high in the first trimester, before many women know that they are pregnant.
Such patients should be informed about the risks of their disease, especially untreated or inadequately controlled epilepsy or bipolar disorder during the pregnancy. They should also be informed about the need to take folic acid before and during the first trimester of the pregnancy in order to minimise the risk of congenital neural tube defects. In order to diagnose neural tube defects and other malformations in pregnant women taking valproate, prenatal diagnostics should be used. If a patient finds out that she is pregnant or is planning a pregnancy, she should consult her physician. The patients should not discontinue their therapy without previously consulting their physician because a sudden discontinuation of the treatment with valproate may cause serious problems.
There are several medicinal products with the active substance valproate (Apilepsin, Depakine Chrono, Depakine Chronosphere) approved for marketing in the Republic of Croatia, and besides, the Agency issues consent for import of medicinal products with the active substance valproate based on prescriptions issued by physicians for specific, individual patients. After the revision of the text on the Summary of Product Characteristics and the Patient Information Leaflet, if necessary, the marketing authorisation holders will be required to introduce new information in these documents. The Agency will continue to monitor the safe use of the medicinal products from the same group.