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Sodium valproate and EMA public hearing: a summary

Wednesday 27 September 2017: There has been a lot of coverage and talk about the anti-epilepsy drug sodium valproate in recent days. Here, we provide a summary.

On Thursday (21 September), Young Epilepsy – along with Epilepsy Action and Epilepsy Society – exclusively revealed to BBC News the interim survey results regarding the risks surrounding childbearing women taking sodium valproate. The results showed an alarming number of women between the ages of 16-50 unaware of the potential risks to their unborn child, including developmental delays.

By analysing the survey, the epilepsy charities found:

  • Almost 1 in 5 (18%) women currently taking the epilepsy medication sodium valproate do not know it can harm the development and physical health of their unborn child should they become pregnant.
  • More than a quarter (28%) of women taking the epilepsy drug have not been given information about risks for their unborn child.
  • More than two thirds (68%) of women taking the epilepsy drug have not received specially produced valproate materials released in February 2016.

These interim results took into account responses from 2,000 women and girls – 475 of whom took sodium valproate. It is the third most commonly prescribed anti-epilepsy drug which is available under various names including Epilim, Episenta, Epival, Convulex and Depakote.

The publicity surrounding the interim results coincided with the European Medicines Agency (EMA) public hearing about the drug. This took place in London on Tuesday (26 September), giving opportunities for medical experts, charities and the general public alike to explain their experiences of sodium valproate. The public hearing was part of a review of the safety of using valproate-containing medicines in women and girls who are pregnant or of childbearing age by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).

Clare Pelham of Epilepsy Society presented the three charities’ findings to the Hearing. Young Epilepsy, with Epilepsy Society and Epilepsy Action, collectively propose that repeat prescriptions for sodium valproate for women and girls of childbearing age should not be routinely renewed for more than 12 months without a face-to-face consultation with a doctor or nurse. This consultation must include personal and tailored information about the risks around sodium valproate during pregnancy. The information should also be provided in written format.

Women and girls of child-bearing potential should only be treated with sodium valproate if nothing else works. It is crucial women and girls do not stop taking their epilepsy medication without talking to a healthcare professional beforehand.

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Cyber EssentialsFundraising RegulatorYoung Epilepsy is the operating name of The National Centre for Young People with Epilepsy Charitable Trust.
Registered Charity number 311877 (England and Wales)

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