New guidance on the prescription of sodium valproate for women of childbearing age

29th April 2019

13 UK healthcare bodies have combined to provide new guidance on the prescription of sodium valproate medications for women of childbearing age. These medications include those under brand names such as Epilim, Epival, Episenta, Convulex and Orlept.

The risks of prescribing sodium valproate

The prescription of sodium valproate to women of childbearing age has long since been known to carry inherent risks, with a 40% increase in risk for neurological disorders and a 10% increase for physical disabilities of unborn children.

Read more about epilepsy care during pregnancy here in one of our previous blog posts.

The existing guidance

Previously guidelines had stated that sodium valproate should not be prescribed to women of childbearing age unless there was no other alternative. Should this be the case they should be fully informed of the risks and ideally enrolled into a pregnancy prevention plan. However, these guidelines have come under scrutiny after a series of complex situations have thrown the debate about patients wellbeing and their best interests.

Claire Glazebrook, Director of Fundraising, Marketing and External Affairs at Epilepsy Society, said: “Over the last year our Helpline has received multiple calls from women, parents and healthcare professionals, all struggling to interpret the guidelines and what they mean for them as individuals. And we know that this experience is replicated across other patient organisations and clinics.

“I hope this guidance will help to answer some of their questions and provide clarity in what can be a very emotional and challenging decision.

“For some girls and women, they have no option but to take sodium valproate as it may be the only drug that will control their seizures. But that, of course, means there are some very important and potentially heartbreaking issues to consider around planning a family.

“All these women and girls deserve consistency in the advice and information that they receive.”

The new guidance

It is hoped the new guidance will allow healthcare professionals to implement the Medicines and Healthcare products Regulatory Agency’s (MHRA) original guidance more effectively when prescribing to varying age groups and help to remove some of the doubt that has been created. This will be a welcome relief to those prescribing physicians who have been in difficult situations when deciding whether to prescribe sodium valproate.

Sanjay Sisodiya, Director of Genomics at Epilepsy Society and Professor of Neurology at University College London said: “In some cases, the new regulations have lead to situations where the best interests of the patients may not appear to be best served. Some of the points raised by the regulations are also complex ethical issues. We do not attempt to address all these issues in this document but hope that it will bring greater clarity for clinicians leading to better care for women and girls with epilepsy. All women and girls have individual needs and where possible should be involved in the choices they make about their own health and plans to start a family.”

Of course, it’s essential that people with epilepsy get the best possible care and receive the medication that is in their best interest. These new guidelines are aimed at aiding healthcare professionals to decide more clearly where the line is for patient wellbeing versus risk to a potential unborn child.

Professor Dame Sally Davies, Chief Medical Officer for England said: “I am very pleased that the Medical Royal Colleges have come together to produce this important and helpful guidance, so that doctors and other healthcare professionals across primary and secondary care are on the same page regarding the use of sodium valproate – including around instances where its use is still appropriate.”

You can read the latest guidance document in full here.

Furthermore, the National Institute for Health and Care Excellence has published a summary on their own recommendations for prescribing sodium valproate medications. You can read those here.

National Epilepsy Training can help…

For more advice or information on sodium valproate medications and their risk to unborn children. Please call us on 01706 373075 or email admin@nationalepilepsytraining.co.uk.