Guidance

Valproate use by women and girls

Information about the risks of taking valproate medicines during pregnancy.

Background

Valproate (Epilim, Depakote and other generic brands) is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy.

Valproate is a treatment for epilepsy and bipolar disorder and is prescribed to thousands of women. Since its introduction in 1974, the product information for doctors has included a warning about the possible risk of birth defects. As the risks to unborn children have been increasingly understood, the warnings have been strengthened.

In March 2018 the CMDh endorsed a strengthened regulatory position on valproate medicines. Valproate must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention programme in place. This is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.

It is important women don’t stop taking valproate without first discussing it with their doctor.

If valproate is taken during pregnancy, up to 4 in 10 babies are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects.

In women who take valproate while pregnant, around 1 in 10 babies will have a birth defect.

Birth defects seen when mothers take valproate during pregnancy include:

  • spina bifida (where the bones of the spine do not develop properly)
  • facial and skull malformations (including cleft lip and palate, where the upper lip or facial bones are split)
  • malformations of the limbs, heart, kidney, urinary tract and sexual organs.

In women who take valproate while pregnant, about 3–4 children in every 10 may have developmental problems. The long-term effects are not known.

The effects on development can include:

  • being late in learning to walk and talk
  • lower intelligence than other children of the same age
  • poor speech and language skills
  • memory problems.

Children exposed to valproate in the womb are more likely to have autism or autistic spectrum disorders. There is also some evidence children may be more likely to be at risk of developing symptoms of attention deficit hyperactivity disorder (ADHD).

Current advice

The CMDh has endorsed the strengthened regulatory position on valproate medicines which MHRA has been championing through the Europe-wide review.

Valproate must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention programme in place. This is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.

These new regulatory measures also include a ban on the use of valproate for migraine or bipolar disorder during pregnancy, and a ban on the use of valproate to treat epilepsy during pregnancy unless there is no other effective treatment available.

It is important women don’t stop taking valproate without first discussing it with their doctor.

Toolkit

Following the CMDh endorsement of a strengthened regulatory position on valproate, these documents are being updated.

View the checklist

View the patient card

View the brochure for patients and in Welsh

View the brochure for healthcare professionals

View the Patient Information Leaflets

Discussing Valproate - a video for GPs, pharmacists and other healthcare professionals, on our latest advice about the toolkit and discussing risk of valproate medicine during pregnancy with their patients (this video was developed by MHRA in collaboration with the Royal College of General Practitioners and the Royal Pharmaceutical Society):

Discussing Valproate

Patient support networks

If you have questions or concerns about the risks associated with valproate and pregnancy, please speak to your doctor, pharmacist or other healthcare professional.

You can also contact a patient support network such as:

Bipolar UK - 0333 323 3880

Epilepsy Action - 0808 800 5050

Epilepsy Society - 01494 601 400

Mind - 0300 123 3393

If you are taking valproate and think you might be pregnant or know you are pregnant, contact your doctor at once so that you can talk through your options.

If you have experienced any side effects to this medicine you can report these to MHRA using the Yellow Card Scheme.

If you or your child has been affected by valproate medicines, you can also contact a support network such as:

OACS - 07904 200364

INFACT/FACSA - 01253 799161

Published 23 March 2018