Support Alert

Drug Safety Update: valproate medicines and serious harms in pregnancy - new annual risk acknowledgement form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme

The Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update advises that ongoing patient survey data suggest that more effort is needed by clinicians to achieve full and timely compliance with the valproate Pregnancy Prevention Programme. The update also highlights new and updated guidance:

  • Revised annual risk acknowledgement form - which should be used during annual specialist review of all women and girls of childbearing potential on valproate medicines (irrespective of indication)
  • NICE guidance summary
  • Pan-college guidance
  • Paediatric guidance

Further details of the Drug Safety Update and advice for healthcare professionals can be found on the MHRA website.

Our ‘Dispensing valproate for girls and women’ guide has also been updated which you can access here.