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;
- 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
- 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.