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
Pregnancy Prevention Programme materials are available on the MHRA website.