Sodium Valproate – an extraordinary scandal

For decades, pregnant women have been taking sodium valproate medicine unaware of the risks it posed. Sodium valproate is often known by the brand name Epilim.

Sodium Valproate, a drug used to treat epilepsy, bipolar disorder and migraines, must no longer be prescribed to females of childbearing age in the UK, unless they sign a form to say that they been informed and understand the risks. High doses of Sodium Valproate can damage unborn babies causing abnormalities such as foetal valproate syndrome (FVS). Babies affected can suffer from a range of problems including cognitive difficulties, learning disabilities and autism, as well as some physical abnormalities. 

This is not new information. The dangerous effects of this drug during pregnancy have been known for some time. It is not only the drug itself which is of concern, but the manner in which it is being prescribed. Research has found that more than one in four women have not been given information about risks to their unborn child, suggesting that doctors prescribing sodium valproate are either unaware of the dangers or have not been passing this information on to women. This is despite a visible warning on the side of valproate packets since 2016.

New regulations have been introduced by the Medicines and Healthcare Products Regulatory Agency (MHRA) around the way in which the drug is prescribed to women and girls of childbearing age. The new measures are designed to ensure that all women who take the drug for their epilepsy, are:

• fully informed of the risks
• advised on the importance of using effective contraception
• invited for a yearly review of their treatment

The MHRA has also changed the licence for valproate, which means any doctor prescribing it will have to ensure female patients are put on a Pregnancy Prevention Programme, which means:

• the patient can see her doctor every year to discuss the risks of this drug to an unborn baby
• she signs an acknowledgement form at least every year
• she is told about the importance of using contraception throughout treatment and having a pregnancy test if she thinks she could be pregnant

Dr June Raine, from the MHRA, said:

“Patient safety is our highest priority. We are committed to making sure women and girls are aware of the very real risks of taking valproate during pregnancy. However, we also know it is vitally important women don’t stop taking valproate without first discussing it with their doctor.”

Simon Wigglesworth, deputy chief executive of Epilepsy Action said:

“We know there are still far too many women who haven’t been made aware of the potential risks of taking sodium valproate in pregnancy. It is vitally important that healthcare professionals ensure that all women with epilepsy taking sodium valproate are reviewed in line with the new guidelines. Those already on valproate medication should see their GP to have their treatment reviewed. No woman or girl should stop taking it without medical advice though”.

If Sodium Valproate is taken during pregnancy, up to four in 10 babies are at risk of developmental disorders, and approximately one in 10 are at risk of birth defects. It is thought about 20,000 children in the UK have been left with disabilities as a direct result of taking the drug since the 1970s. Affected families have called for a public inquiry and compensation.

Mr Lamb, a former Minister for Care and Support, is part of a campaign calling for the Government to back compensation claims. He said the harm caused to children after their mothers were given sodium valproate is an “extraordinary scandal”.

As professionals who work with people with epilepsy, we are concerned women continue to be misinformed or not fully advised about the dangers posed by sodium valproate. We support the work of epilepsy charities in this area.

For more information

If you believe that you or a loved one maybe affected by these issues or would just wish for further clarification of anything arising from this article then please contact Stephanie Moustache.

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