New guidance has been issued on the use of valproate in women with epilepsy or bipolar disorder, after a Europe-wide review found that children exposed to the drug in utero are at high risk of serious developmental disorders including autism (in up to 30–40% of cases) and/or congenital malformations (in approximately 10% of cases).
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Female patients (including children, adolescents and women of childbearing potential) should be informed of the risks associated with the use of valproate (including sodium valproate, valproic acid and valproate semisodium) during pregnancy and the need to use effective contraception. Treatment should be regularly reviewed and prescribers should advise women to seek medical advice rapidly if they are planning a pregnancy or become pregnant.
Sodium valproate (eg, Epilim, Episenta) and valproic acid (Convulex, Depakote) are now black triangle medicines and are therefore subject to additional monitoring via the .