Valproate Licence Change

The Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licence for valproate medicines (Epilim, Depakote and generic brands) so it must no longer be prescribed to women or girls of childbearing potential unless they are on the Pregnancy Prevention Programme (PPP).

This is because valproate is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy. The change in licencing is to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.

The PPP includes the completion of a signed risk acknowledgement form when their treatment is reviewed by a specialist, at least annually. All women and girls who are prescribed valproate should contact their GP and arrange to have their treatment reviewed. No woman or girl should stop taking valproate without medical advice.

These regulatory changes will be further supported in the upcoming months by:

  • smaller pack sizes to encourage monthly prescribing; and
  • a pictogram/warning image on valproate labelling.

For further information including an MHRA toolkit and links to patient support networks, please visit the GOV.UK website.