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Originator: CMO Messaging

From: Professor Dame Sally C Davies - Chief Medical Officer - Department of Health

Issue date: 24-Apr-2018 09:36:34

This alert has been issued to:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Foundation Trusts (England) - Chief Executive
  • NHS Trusts (England) - Medical Director
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • CMO Urgent Messages - Recipients on Public Health Link
  • NHS Trusts (England) - Chief Executive

  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • Social Care Providers (registered with CAS)
  • Special Health Authorities
  • CMO Urgent Messages - Non-NHS Recipients on Public Health Link
  • Director of Public Health

Action category: Important information for immediate action

Title: Valproate contraindicated in women of childbearing potential unless there is a Pregnancy Prevention Programme

Broadcast content:

Use of valproate medicines in pregnancy is associated with a 40% risk of persistent neurodevelopmental disorders and a 10% risk of physical birth defects.  Despite repeated communications on this risk, it is estimated that 400 women in the UK took valproate medicines during pregnancy in 2016.

Following a review of the situation across the EU, valproate is now contraindicated in women of childbearing potential unless they meet the conditions of a Pregnancy Prevention Programme, which will include a risk acknowledgment form to be completed and signed by the specialist prescriber and the patient in a review at least once a year.

Please see the letter attached for actions required from the healthcare system.

For details on the new regulatory measures, see the MHRA website.

Additional information: Regional Offices: please cascade to general practice and pharmacy.

Alert reference: CEM/CMO/2018/001

Cascade to:
  • #GP#
  • #NURSES#
  • #HospitalPharmacy#

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency