New Guidance on Valproate for Women of Childbearing Age

Peter Russell

April 01, 2019

New "pragmatic" guidance was issued to support doctors and other health professionals around the use of sodium valproate (Epilim, Depakote, Sanofi-Aventis and other brands) in women and girls during their reproductive years.

The guidance, based on input from 13 professional bodies, including seven Royal Colleges, addressed some of the "challenging situations" that clinicians might face when considering prescribing valproate.

Publication coincided with an updated summary by the National Institute for Health and Care Excellence (NICE) which brought together all its recommendations and safety advice from other sources for healthcare professionals on valproate use.

Risk of Birth Defects

Valproate is licensed for use to treat epilepsy and bipolar disorder. It is also used off-label for depression, neuropathic pain, dementia and migraine. It is associated with a significant risk of birth defects, including spina bifida and face and skull malformations, and developmental disorders in children born to females who take valproate during pregnancy.

Up to 4 in 10 babies born to mothers who take valproate while pregnant are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects.

In 2018 the Medicines and Healthcare products Regulatory Agency (MHRA) introduced restrictions on the use of valproate, which effectively banned its use for women in their childbearing years unless there was no alternative treatment and they were on a pregnancy prevention programme.

'Many Grey Areas'

Ley Sander, professor of neurology at University College London, and medical director at the Epilepsy Society, said: "The new regulations around prescribing sodium valproate to girls and women of childbearing age have thrown up many challenges for healthcare professionals since they became mandatory last year.

"There have been many grey areas around the pregnancy prevention programme and I hope that the updated guidance, in tandem with the new guidance from a consortium of UK healthcare bodies, will help bring clarity for both specialists and women and girls with epilepsy."

The authors of the new guidance said they could not hope to cover every ethical issue but that it brought together data and best practice to guide clinicians, and signposted a wide range of helpful resources.

Other areas covered by the guidance included the transition from paediatric to adult services, treatment of patients with intellectual disability, confidentiality, and women on valproate detained in prison.

Prof Helen Stokes-Lampard, chair of the Royal College of General Practitioners, said: "The care of women with epilepsy can span GP and specialist care and I do hope this guidance will provide much-needed support to doctors across all medical specialties, helping them to act in the best interests of the individual girl or woman, and ultimately improve the care we provide to our patients."

Report co-author Prof Sanjay Sisodiya representing the Royal College of Physicians and the Association of British Neurologists said: "The regulations around valproate have been well publicised. Their implementation in practice can throw up difficult situations. We hope that this document will provide both practical guidance and an illustration of the general approach which will be of value to clinicians.

"We hope also that the joint provenance of the guidance will ensure consistent messages for clinicians and patients. We realise that additional changes may occur and intend to update the document over time."

Carmel Bagness from the Royal College of Nursing said:  "The guidance recognises the extra support needed by women with epilepsy when they become pregnant, and the difficult decisions that sometimes need to be taken.

"Having clinically-backed information on best practice will be a great help to nursing and midwifery staff."

New NICE Visual Summary

NICE said its new summary sheet on valproate brought together existing information and advice on safe prescribing from other sources with its own existing guideline recommendations in an easy-to-access visual summary.

Paul Chrisp, director of the Centre for Guidelines at NICE, said: "We worked closely with the MHRA to ensure that our guidelines which mention valproate were amended last year in order to signal the need for clinical practice to align with their revised regulatory position on valproate.

"This summary is a continuation of that work. It recognises the importance of a single cross-disciplinary valproate guideline to support healthcare professionals from all disciplines in the safe use of valproate and it will help to ensure that children are not exposed to valproate through their mother during pregnancy."

Philip Lee, chief executive at Epilepsy Action, commented: "There is evidence to suggest that women and girls are still not being made aware of the risks associated with sodium valproate in pregnancy. We therefore welcome this summary guidance, which highlights best practice in prescribing sodium valproate for women and girls of childbearing potential. Though the information is not new, it could prove a useful tool for guiding clinical practice.

"It is crucial that the guidance is effectively publicised and disseminated, so that all relevant clinicians are aware of it. It is vitally important that healthcare professionals ensure that women with epilepsy taking sodium valproate are reviewed in line with all recent guidance and regulations."


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