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Originator: National Patient Safety Alert - MHRA

Issue date: 28-Nov-2023 16:34:20

This alert has been issued to:
  • Care Trusts
  • Mental Health Trusts
  • Other contacts
  • Specialists Trusts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Regional Offices
  • Learning Disabilities Trusts
  • Mental Health & Social Care Trusts
  • Ambulance Trusts
  • Social Care Providers (registered with CAS)
  • Special Health Authorities
  • Mental Health & Learning Disabilities Trusts
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • Director of Public Health
  • Acute Trusts
  • Community Trusts
  • GP - Locum
  • NHS 111 and Out of hours providers
  • GP Practices
  • Integrated Care Boards
  • Community Pharmacy
  • Primary Care Networks
  • GP Practices 1

Action category: Action

Title: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients

Broadcast content:

The MHRA is asking organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semisodium (valproate). This follows a comprehensive review of safety data, advice from the Commission on Human Medicines and an expert group, and liaison with clinicians and organisations.

Due to the known significant risk of serious harm to a baby after exposure to valproate in pregnancy, these measures aim to ensure valproate is only used if other treatments are ineffective or not tolerated, and that any use of valproate in women of childbearing potential who cannot be treated with other medicines is in accordance with the Pregnancy Prevention Programme (PPP). Given these and other risks of valproate, these measures also aim to reduce initiation of valproate to only in patients for whom no other therapeutic options are suitable.

The attached alert provides further information and detailed actions.

We are not collecting any responses from NHS Trusts via the CAS website to this alert as we will be collecting feedback at ICB level in England, through Health Boards (in Scotland), Health Boards (in Wales), and Health and Social Care Trusts (in Northern Ireland).

Additional information: NHS England Regions: please cascade this alert to community pharmacy contractors.

Alert reference: NatPSA/2023/013/MHRA


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Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency