Dark Side of Medicine™
The Pregnancy and
Sodium Valproate
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Recognised Risks
Sodium valproate is a known teratogen, meaning that exposure during pregnancy can affect the developing baby. Current UK guidance states that around 30–40% of children exposed to valproate in pregnancy may experience problems with early development, while approximately 1 in 9 (11%) may have a physical birth defect. Research has suggested that the proportion experiencing neurodevelopmental difficulties may be higher in some populations. These effects can vary considerably between individuals and form part of the wider spectrum of outcomes associated with prenatal valproate exposure.
Pregnancy Prevention Programme (PPP)
The Pregnancy Prevention Programme (PPP) was introduced to reduce the risk of babies being exposed to sodium valproate during pregnancy. It requires women and girls who could become pregnant to be informed about the risks, use effective contraception where appropriate, and have their treatment reviewed regularly by a specialist. The programme is supported by patient information and risk acknowledgement materials designed to help ensure that the risks of pregnancy are understood throughout treatment.
Current Guidance
UK guidance for sodium valproate has changed considerably as understanding of its reproductive risks has developed. Current recommendations apply to both women and men taking valproate. For the most recent prescribing requirements, reproductive-risk advice and patient information, please refer directly to the Medicines and Healthcare products Regulatory Agency (MHRA).