The MHRA has determined that valproate medicines should now be contraindicated in women & girls of childbearing potential unless the conditions of a new Pregnancy Prevention Programme are met.
The April 2018 edition of the MHRA Drug Safety Update includes the following advice for healthcare professionals:
- GPs must identify and recall all women and girls who may be of childbearing potential, provide the Patient Guide and check they have been reviewed by a specialist in the last year and are on highly effective contraception
- Specialists must book in review appointments at least annually with women and girls under the Pregnancy Prevention Programme and re-evaluate treatment as necessary; explain clearly the conditions as outlined in the supporting materials; and complete and sign the Risk Acknowledgement Form—copies of the form must be given to the patient or patient/caregiver/responsible person and sent to their GP
- use of valproate in pregnancy is contraindicated for bipolar disorder and must only be considered for epilepsy if there is no suitable alternative treatment