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26 October 2016

Worrying lack of knowledge over epilepsy medicine risks in pregnancy

  • Almost half (48%) of women with epilepsy are unaware of the risks of taking epilepsy medicine sodium valproate
  • 1 in 5 (20%) women currently taking the drug do not know it can harm the development and physical health of their unborn child should they become pregnant
  • Charities are urging healthcare professionals and the Department of Health to ensure women are aware of the risks before they conceive

Almost half (48%) of women with epilepsy are unaware of the risks of taking epilepsy medicine sodium valproate, according to a new survey by three leading UK epilepsy charities.  More concerning is that 1 in 5 (20%) women currently taking the drug do not know it can, in a minority of cases, harm the development and physical health of their unborn child should they become pregnant.

More than 2,700 women with epilepsy took part in the survey, conducted by Epilepsy Action, Epilepsy Society and Young Epilepsy. The survey revealed that just over a quarter (27%) of women who responded, and are currently taking sodium valproate, had not had a discussion led by their healthcare professional about the risks involved in pregnancy.

The charities are now calling on the Department of Health to continue to support efforts to ensure that all women are aware of the risks, and are able to make informed decisions about their care. The organisations say it is imperative that healthcare professionals are given the time and resources to make sure these conversations happen.

The Medicines and Healthcare products Regulatory Agency (MHRA) recently launched a toolkit to help healthcare professionals talk to women with epilepsy about the risks involved during pregnancy. The toolkit features a credit card-sized patient card to be issued by pharmacists, booklets for healthcare professionals and women taking sodium valproate, and a checklist of important discussion points. The MHRA has also produced a learning video, available on youtube, for GPs to encourage them to review their female patients on valproate and to make sure they are aware of the risks of taking the medicine during pregnancy. It calls on GPs to read the patient information leaflet from the toolkit and use the checklist to facilitate discussion with their patients.

Professor Ley Sander, medical director of Epilepsy Society and professor of neurology at University College London Institute of Neurology, said: “The majority of women with epilepsy enjoy healthy pregnancies and give birth to healthy babies. However, these figures highlight a pressing need for women to have the right information about all aspects of pregnancy and the risks linked with sodium valproate.

“The MHRA strengthened the warnings last year on the risks of sodium valproate in pregnancy. Pre-conception counselling is essential to ensure women and girls with epilepsy are fully informed of the risks associated with pregnancy. These include the possibility of developmental disorders and birth defects in babies exposed to sodium valproate during pregnancy.

“Healthcare professionals need to be supported with the time and tools to help women have these important conversations. The toolkit is an invaluable resource to open up the dialogue with patients to help them make an informed choice and manage their care before, during and after pregnancy. This will help to reduce the risks of malformations in babies born to women with epilepsy.”

Sodium valproate (often known under brand names such as Epilim, Epival, Episenta, Convulex and Orlept) is currently the third most-prescribed epilepsy medicine.  According to the MHRA, up to four in 10 babies are at risk of developmental disorders if sodium valproate is taken during pregnancy and one in 10 babies are at risk of being born with a birth defect. The MHRA also states that women and girls of child-bearing potential should only be treated with sodium valproate if nothing else works. 

To find out more and to access the toolkit, visit www.gov.uk/government/publications/toolkit-on-the-risks-of-valproate-medicines-in-female-patients

 

For advice and information about epilepsy and pregnancy for healthcare professionals, visit the charities’ websites: epilepsy.org.uk, epilepsysociety.org.uk and youngepilepsy.org.uk

 

 

 

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