Royal Colleges publish new guidance around use of valproate for women and girls of childbearing age with epilepsy

New guidance brings greater clarity for doctors and patients in implementing MHRA regulations around use of sodium valproate for women and girls of childbearing age with epilepsy

Charity hopes guidance will help to address some of the complex situations that arise in individual cases

New guidance to support regulations around the use of valproate in women and girls of child bearing age with epilepsy has been published by specialists from the Royal Colleges of General Practitioners, Physicians, Psychiatrists, Paediatrics and Child Health, Obstetricians and Gynaecologists Midwives and Nursing.

Risks around sodium valproate

The use of sodium valproate during pregnancy is associated with up to a 40 per cent risk of neuordevelopmental disorders and a 10 per cent risk of physical disabilities for an unborn child.

In March 2018, the Medicines and Healthcare products Regulatory Agency published guidelines which meant that valproate should no longer be prescribed for girls and women of childbearing age unless no other effective treatment was available.

Any girl or woman prescribed valproate should also be fully informed of the risks associated with the medication.

Challenges around the mandatory guidelines

But a year on, implementation of the guidelines has thrown up challenges in relation to some complex issues, as well as individual situations where the best interests of the patient did not appear always to have been met.

Clare Pelham, Chief Executive at Epilepsy Society, said: "Over the last year our Helpline has received multiple calls from women and girls, their 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 to enable them to take 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 need to be able to have confidence in the advice and information that they receive, so that they can make informed decisions."

Experts draw up the supportive guidance

The new guidance has been drawn up by Judy Shakespeare of the Royal College of General Practitioners and Sanjay Sisodiya of the Association of British Neurologists and Royal College of Physicians. Sanjay Sisodiya is also Director of Genomics at Epilepsy Society and Professor of Neurology at UCL.

He said: This work has come together through much valued contributions from specialists across all the Medical Colleges.

“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 fertility."

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."

More information

You can read the guidance from the colleges here (pdf) or access the website here.

Read about the NICE updated guidance for healthcare professionals.