Valproate pregnancy prevention programme

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;

• Pregnancy
• Women of childbearing potential unless the conditions of the pregnancy prevention programme are fulfilled

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

• Pre-pubescent
• Post menopausal
• Confirmed infertility
• Confirmed sterilisation
• Confirmed hysterectomy

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:

• fully informed of the risks
• are provided with highly effective contraception to prevent unplanned pregnancy.

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:

• Progestogen-only injections e.g. Depo-Provera have a typical-use failure rate of 6%, but this may be due to repeat injections being administered late. Progestogen-only injections may be considered highly effective if repeat injections are documented as having been administered on schedule by a healthcare professional.
• User dependent methods of contraception are not considered highly effective.

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.