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Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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A pregnant lady imageSeptember 26 2017

Almost a fifth of women with epilepsy (18%) who take sodium valproate are not aware of the potential risks the medicine can pose during pregnancy. The survey also found that 28% of the women currently taking sodium valproate said they had not been informed of the risks.

 The new survey of 2,000 women with epilepsy, aged 16-50, was conducted by Epilepsy Action, the Epilepsy Society and Young Epilepsy. It followed up on a similar survey a year ago, which had similar results. In 2016, 20% of respondents said they did not know the risks of taking sodium valproate during pregnancy and 27% of women taking the drug said they had not had a discussion with their healthcare professional about the risks in pregnancy.

The charities are concerned that a valproate toolkit put out by the medicines regulator, the MHRA in February 2016, has not been used sufficiently. The 2017 survey found that “more than two-thirds of women (68%) taking sodium valproate said they have not received any materials from the MHRA toolkit.”

Sodium valproate is linked to an increased risk of birth defects and developmental problems in babies born to mothers taking the medicine, said Epilepsy Action. “The risk of physical disabilities in babies born to women taking sodium valproate is estimated to be around 1 in 10 (10%). The risk of developmental problems, which can lead to learning difficulties, is around 2 in 5 (40%).”

Philip Lee, chief executive at Epilepsy Action, said: “It is vital that women with epilepsy get the right information about their care and treatment to ensure a healthy pregnancy and minimise the risks associated with sodium valproate.

“Yet these figures suggest that information is not filtering down to women and that conversations about the potential risks are not always happening. Discussions with a health professional about these risks should be a mandatory part of care for all women with epilepsy so they can make informed choices, ideally before they conceive.”

The survey findings have been published ahead of a public hearing on valproate being conducted by the European Medicines Agency on September 26. The hearing will take place in London, and follows requests by EU member states to review how effective nationally-implemented measures have been in increasing awareness and reducing valproate use appropriately.

The Association of the British Pharmaceutical Industry issued a statement ahead of the EMA hearing. Dr Virginia Acha, the ABPI's Executive Director of Research, Medical and Innovation, said: “For each and every patient, it is absolutely critical that the risks and benefits of medicines are identified, considered and continually monitored. This is certainly the case for patients suffering from epilepsy where despite the availability of several effective treatments, used to help people live active lives, thousands of British patients still have no effective control.

“Patients and their doctors should continue to refer to the MHRA’s excellent toolkit and guidance that ensures everyone is better informed about the risks of taking valproate medicines during pregnancy. Anyone who is worried should speak to their healthcare professional.”

Links:
Epilepsy Action announcement
MHRA ‘Toolkit on the risks of valproate medicines in female patients’        
EMA review       
ABPI statement                

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