Reproductive Safety and Sodium Valproate

BACKGROUND

Sodium valproate is an anti-seizure medication, approved for use in the treatment of epilepsy and bipolar disorder, and  widely used for neuropathic pain and migraine prophylaxis.

Despite decades of published evidence and ongoing regulatory warnings about sodium valproate's significant dose-related teratogenic and neurodevelopmental risks when used during pregnancy, there has been a lack of uniform guidance in Australia for clinicians and patients, contributing to clinical uncertainty, inconsistencies in risk communication, and variable standards in consent and prescribing practices. 

To address this gap in guidance, Viandro Borja FANZCAP (Lead&Mgmt, MentalHlth), Chair of the AdPha Mental Health Leadership Committee, led a collaboration of members from the Mental Health Specialty Practice Group (SPG), Women's & Newborn Health SPG, Paediatrics & Neonatology SPG and Medication Safety SPG to develop Consensus Guidance: Reproductive Safety and Use of Sodium Valproate.

DOWNLOAD GUIDANCE 

CONTRIBUTORS

Viandro Borja FANZCAP (Lead&Mgmt, MentalHlth) | Mental Health Leadership Committee

James Dwyer FANZCAP (Lead&Mgmt, MedSafety) | Women’s & Newborn Health Leadership Committee

Dr Alka Garg | former member Paediatrics & Neonatology Leadership Committee

Katie Ho FANZCAP (Lead&Mgmt, MentalHlth) | former member Mental Health Leadership Committee

Tamara Lebedevs FANZCAP (MedInfo, ObsGynae) | Women’s & Newborn Health Leadership Committee

Judy Longworth FANZCAP (MentalHlth, Paeds) | former member Mental Health Leadership Committee

Dr Treasure McGuire FANZCAP (Edu., ObsGynae) | Women’s & Newborn Health Leadership Committee

Lisa Robertson FANZCAP (Lead&Mgmt, MedSafety) | Medication Safety Leadership Committee

Suzanne Newman ANZCAP-Reg. (Generalist) | AdPha Member Projects Manager

ACKNOWLEDGEMENTS

AdPha acknowledges the following organisations for their review of draft versions of this guidance:

  • MotherSafe
  • Safer Care Victoria
  • Society of Obstetric Medicine of Australia and New Zealand (SOMANZ)
  • The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG)