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Valproate salts are known to be teratogenic. Evidence suggests that 1 in 10 children exposed to valproate in utero will develop a physical birth defect and up to 40% will have early developmental problems that can lead to significant learning disabilities.
Use of valproate is now contra-indicated in the following circumstances;
This means the use of valproate in women of childbearing potential without meeting the conditions of the pregnancy prevention programme is contra-indicated and therefore off-label.
A woman would not be considered of childbearing potential if
If a women's fertility status changes patients should be recalled for urgent assessment.
N.B This list is not exhaustive.
The MHRA introduced a pregnancy prevention programme called Prevent for valproate in March 2018. All women of childbearing potential prescribed valproate salts are expected to participate in the Prevent programme.
The aim of the programme is to prevent harm to unborn children exposed to valproate by ensuring that women of childbearing potential are:
Highly effective contraception is considered to be copper intra-uterine devices, levonorgestrel intra-uterine devices or progesterone only implants. Women should be referred to Sandyford sexual health services for appropriate contraceptive treatment.
The HCP guide was updated in November 2019 and makes the following additional statements about contraception:
Materials produced by the MHRA to support this programme can be found at this link.
Guidance for mental health services on how to implement the Prevent programme can be found here.
These include a risk assessment form that must be used to record the annual conversations and consent process for all women of childbearing potential prescribed valproate salts.
If a woman having heard and understood the risks wishes to remain on valproate but does not wish to participate in the Prevent programme this decision must be fully documented and revisited annually.
Last reviewed: 19 August 2020
Next review: 01 July 2022
Approved By: Mental Health Clinical Governance & Quality Group
Reviewer Name(s): Lead Clinical Pharmacist, Clinical Effectiveness Pharmacist