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Demand for stronger warnings on epilepsy drug sodium valproate

The families harmed by the epilepsy drug sodium valproate are demanding a public inquiry and compensation, following a public hearing in London on Monday which assessed if the current warnings for patients were adequate.


The families harmed by the epilepsy drug sodium valproate are demanding a public inquiry and compensation, following a public hearing in London on Monday which assessed if the current warnings for patients were adequate.

The current guidance says women of child-bearing age should only take sodium valproate as a last resort, however the European Medicines Agency (EMA) is currently assessing whether these warnings are strong enough.

Campaigners believe the warnings to those of child-bearing age, that the drug could cause birth defects and developmental problems to their babies could and should have been made public more than 40 years ago.

What is Sodium Valproate? Sodium Valproate is prescribed to treat epilepsy, bipolar and migraines. It can be taken by both adults and children, and is often prescribed as the best option for women.

The drug which can be taken in liquid or tablet form is also called Epilim.

Complications. Current guidelines say valproate should not be used during pregnancy unless there is no safer option, and only after careful consideration of the risks involved.

The drug carries a 10% risk of physical abnormalities and a 40% risk of autism, low IQ and learning disabilities. Sodium Valproate has been prescribed since the 1970s, but the additional warnings were only put on the outside of the packets last year. It is estimated that 20,000 children in Britain have been affected.

An initial court case by families in England and Wales in 2010 had to be abandoned when legal aid was withdrawn. It’s likely that this recent media coverage will open the floodgates for victims and their families to come forward.

Medicines Watchdog the MHRA says the decision to use any medicine during pregnancy requires careful evaluation, and that the safety of valproate in pregnancy was kept under constant review. The updated warnings on the outside of packets last year, were included as new data became available.

Following the public hearing this week, the EMA’s risk assessment committee will now decide what extra measures should be taken to safeguard women of child-bearing age, and will report on the review’s findings by the end of the year.

If you were prescribed sodium valproate during your pregnancy and have any concerns, please contact us on 01603 877000 or email Sara Westwood, sarawestwood@mjp.co.uk.

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