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sodium valproate guidelines

New regulations have been introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) around the way in which the drug, sodium valproate is prescribed to women and girls of childbearing age. Sodium valproate is associated with risks for babies exposed to the drug during pregnancy. The new measures are designed to ensure that all women who have to take the drug for their epilepsy, are fully informed of the risks, are advised on the importance of using effective contraception and are invited for a yearly review of their treatment. 

What is sodium valproate?

Sodium valproate is an epilepsy drug prescribed for all seizure types including absence, myoclonus and tonic clonic seizures. It is also prescribed to a lesser degree for bipolar disorders. It is known under different brand names including Epilim, Epival, Episenta and Convulex.

How effective is sodium valproate in the treatment of epilepsy?

For many people sodium valproate is effective in controlling epileptic seizures and for some women with epilepsy may be the only medication that works. 

What are the risks around sodium valproate?

If a baby is exposed to the drug during pregnancy, there is a risk of it being born with physical disabilities and developmental issues. This applies whether valproate is taken alone or in combination with other medicines.

The risk of disabilities such as spina bifida is approximately 10 per cent while studies show that up to 30-40 per cent of babies exposed to the drug in the womb experience delays in their early development such as talking, and/or walking, have low intellectual abilities, poor language skills and memory problems.

Should you stop taking sodium valproate straight away?

You should never stop taking your epilepsy medication without first consulting your doctor. This also applies if you are pregnant. In some circumstances seizures can cause miscarriage, trauma related to falls and may harm your baby. Even if you are not pregnant, seizures can pose a risk to your well being. It is important to seek the advice of your doctor and look at changing slowly to a different medication.

What are the new measures around sodium valproate?

The MHRA have changed their regulations to introduce a number of safety measures, including the recommendation that sodium valproate must no longer be prescribed to women and girls of childbearing age, unless they are on a pregnancy prevention programme. This is because of the risk of birth defects and developmental disorders for an unborn baby.

What does this mean for you?

This means that if your doctor decides, in collaboration with you and/or your parent or legal guardian, that sodium valproate is the only medication that will effectively control your seizures, they must also discuss the need to use effective contraception to prevent you from getting pregnant.

Depending on the type of contraception that you and your doctor consider to be best, regular pregnancy tests might be needed to make sure you are not pregnant.

Your epilepsy specialist or GP must also invite you for a review of your epilepsy and medication at least once a year. This is an important opportunity to review your treatment and discuss the risks around the medication. You and your doctor will both need to sign a form acknowledging that you have discussed and understand the risks.

Make an appointment to talk to your doctor or specialist and arrange to have a review if you haven't already been invited for one.

What should you do if you are not planning to start a family?

It is still important to take effective contraception to ensure that you do not become pregnant. As above, you must have an annual review with your specialist. Depending on the type of contraception you use you may also need to take a regular pregnancy test and sign a risk acknowledgement form.

What should you do if you are planning to start a family?

Make an appointment to see your doctor as early as possible and discuss your treatment options. Never stop taking your sodium valproate or contraception but discuss with your doctor the safest options to ensure your safety and that of any future babies.

What should you do if you are pregnant?

Do not stop taking your medication but make an appointment to see your doctor immediately. You will be able to discuss together the best form of treatment to safeguard the well being of both you and your baby. In some circumstances you may not be able to switch to another medication and your doctor will provide you with more information. You will be closely monitored to ensure you have the best seizure control and to check how your baby is developing.

What should happen if you are prescribed sodium valproate?

  • your doctor should talk to you about the risks to babies during pregnancy and the importance of using an effective contraception
  • they should ensure you have seen a specialist in the last year
  • they should offer you an updated patient information booklet for more information
  • both you and your doctor should sign a risk acknowledgement form showing that you have been informed of and understand risks associated with valproate.

When you receive your medication, your pharmacist should:

  • show you the warning on the packaging that contains your medication
  • make sure you have the patient card and leaflet  about sodium valproate
  • check that you have seen your doctor to discuss risks and measures for women and girls.

If you have any questions around sodium valproate, epilepsy, pregnancy and contraception, please contact our helpline on 01494 601 400 or helpline@epilepsysociety.org.uk

The following groups have been set up by patients to help women who have children affected by valproate during pregnancy:

FACS-aware  0116 220 0486
In-FACT/FACSA 01253 799 161
OACS 07904 200364