Guidance

Toolkit on the risks of valproate medicines in female patients

Information about the toolkit to ensure female patients are better informed about the risks of taking valproate medicines during pregnancy.

Documents

Guidance on using the valproate toolkit for those prescribing and dispensing valproate

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Brochure for healthcare professionals

Valproate guide for patients

Valproate guide for patients in Welsh

Prescriber Checklist

Patient Card

For use by GP practices: Template letter for women of childbearing age on valproate containing medicines

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Details

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.

MHRA has worked with industry, healthcare professionals and patient groups on a toolkit to ensure female patients are better informed about the risks of taking valproate medicines during pregnancy.

The risk of developmental disorders is up to 4 in 10 and the risk of birth defects is approximately 1 in 10.

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

Valproate should not be used in female children, in female adolescents, in women of childbearing potential and in pregnant women unless other treatments are ineffective or not tolerated. Women of childbearing potential must use effective contraception during treatment.

No-one should stop taking valproate without discussing it first with their doctor and the benefits of valproate treatment must be carefully balanced against the risks.

If valproate is the only option, women of childbearing age should be given effective contraception. Women taking valproate must have regular reviews of their treatment.

Toolkit

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

View the MHRA statement welcoming the launch of the toolkit.

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 020 8386 9271

INFACT/FACSA 01253 799161

Published 8 February 2016
Last updated 13 September 2017 + show all updates
  1. Removed link
  2. Updated to include guidance on using the valproate toolkit for those prescribing and dispending valproate.
  3. Added learning video for GPs - discussing valproate.
  4. Added link to the Patient Information Leaflets.
  5. Added links to the Welsh versions of the booklet for patients and Patient Information Leaflet.
  6. First published.