New Guidelines For The Use Of Valproate

Published on: 13/04/2019

Valproate, and all it’s forms, are medications primarily used to treat epilepsy and bipolar disorder and to prevent migraine headaches. The most common brand names of Sodium Valproate are Epilim, Episenta and Epival. New regulations have been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) regarding the use of Valproate in girls and women of childbearing potential in March 2018.

Why has Valproate been reviewed?

Valproate is a treatment given for epilepsy and bipolar disorder, and thousands of women are prescribed this medicine each year. Research shows that the treatment is associated with a significant risk of birth defects and developmental disorders and so must no longer be prescribed to any woman or girl of an age they are able to have children.

Risks to your unborn baby

If you take valproate when you are pregnant it can seriously harm your unborn baby.

• The risks are higher with valproate than with other medicines for epilepsy or bipolar disorder.

• The risks are present even with smaller doses of valproate.

• For women who take valproate while pregnant, around 10 babies in every 100 will have a birth defect.

• For women in general, around 2 to 3 babies in every 100 will have a birth defect.

When the baby is born

Taking valproate whilst pregnant can harm your child in two ways:

• Birth defects when the baby is born.

• Problems with development and learning as the child grows up.

• Spinabifida – where the bones of the spine do not develop properly.

• Face and skull malformations – including ‘cleft lip’ and ‘cleft palate’. This is where the upper lip or bones in the face are split.

• Malformations of the limbs, heart, kidney, urinary tract and sexual organs.

Pregnancy Prevention Plan

If you are considered old enough to get pregnant, but have no current interest in becoming pregnant, a doctor can prescribe you Valproate if they feel there is no other alternative medicine that is right for you. You will be asked to take a pregnancy test before the medication is considered, and you may be asked to repeat the test at intervals throughout your treatment.

It is important you always use effective contraception at all times during your treatment with Valproate, to avoid any chance of becoming pregnant.

If you decide you want to become pregnant, do not stop taking your medication and contraception. Discuss with your doctor or specialist what other medications or treatment is available to you, and have a plan in place for your condition. Wait until your health professional agrees it is safe to stop taking Valproate, before you try and conceive.

Where to find further information

The National Institute for Health and Care Excellence (NICE) have provided up to date clinical guidelines for all health professionals in regards to using Valproate during Antenatal and Postnatal care. However this information is also available to women who have, or are at risk of, mental health disorders during pregnancy and the postnatal period and their partners and family.

https://www.nice.org.uk/guidance/cg192#163961_20190402035452

If you have any concerns about Valproate and pregnancy it is advised you speak to a health professional urgently