MHRA: new guidance for women on valproate and pregnancy

The announcement comes as the result of a European review of sodium valproate last year. The review found that up to 40 per cent of children born to women who took valproate during pregnancy experienced adverse effects. These children demonstrated problems including neurodevelopmental disorders as they grew.

Neurodevelopmental disorders are neurological conditions. They originate in childhood and can take various forms, affecting things like learning and understanding, behaviour and language. Neurodevelopmental disorders include autistic spectrum disorders (ASD) and attention deficit hyperactivity disorder (ADHD).

The findings of the European review led to stronger warnings in sodium valproate’s information leaflets. In turn, the MHRA has now called upon medical professionals to make sure that they are explaining the potential risks to an unborn child and discussing them with women with epilepsy.

Aside from the risks of neurodevelopmental disorders, sodium valproate also increases the risk that a baby may be born with a birth defect. Birth defects include things like a cleft palate.

There are around 35,000 women in the UK who take sodium valproate. Around 375 of them become pregnant each year. These women particularly should be aware of risks and the potential implications for treatment and pregnancy.

Epilepsy Action welcomes the strengthened guidance on sodium valproate. However, the organisation stresses that – despite risks – sodium valproate is still an effective treatment option. For some women it may be the only drug that will control seizures. It should only be stopped or changed after careful consideration of the risks and benefits and discussion with a health professional.

Simon Wigglesworth, deputy chief executive at Epilepsy Action, said: “We welcome this new, stronger guidance for clinicians. For a number of years we have highlighted the need for consistent communication of the risks associated with sodium valproate for women with epilepsy. This is a positive step. It clearly outlines the advice doctors should be giving women with epilepsy about the drug.

“If you are taking sodium valproate, or your doctor is considering prescribing sodium valproate for your epilepsy, you should read the new patient advice booklet. It explains that if you are a woman of child bearing potential, your doctor should only prescribe sodium valproate if nothing else works for you. If you still have concerns after reading the information, you should urgently speak to your doctor. However, you should not stop taking your epilepsy medicine as that could be dangerous for you, and if you are pregnant, your unborn baby.”

Epilepsy Action has updated its advice and information pages in the light of the new guidance.

Read information about planning a baby.

Read more information about epilepsy medicines and pregnancy.

Read more information about contraception advice for women on sodium valproate.

You may also like...

Committee recommendation: restrict valproate in women

The Pharmacovigilance and Risk Assessment Committee (PRAC) has assessed the use of valproate in pregnant women. Their recommendations call for tighter restrictions on its use