Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)
Guidance has been published to support initiation of valproate in female patients and for annual review and pregnancy testing during the coronavirus pandemic.
Temporary guidance for specialists
Valproate is harmful if used in pregnancy. Children exposed to valproate in utero have a very high risk for congenital malformations (10% risk) and neurodevelopmental disorders (30–40% risk). Valproate medicines (for any indication) are therefore contraindicated in girls and women of childbearing potential unless the conditions of the Pregnancy Prevention Programme (PPP) are fulfilled.
On 6 May we published guidance for specialists to support adherence to the pregnancy prevention requirements for girls (of any age) and women of childbearing potential taking valproate during the pandemic, particularly patients who are shielding due to other health conditions.
See MHRA guidance at gov.uk/guidance/valproate-pregnancy-prevention-programme-temporary-advice-for-management-during-coronavirus-covid-19
The valproate PPP states that patients on valproate who have experienced menarche must have a review at least annually with the prescribing specialist to reassess the need for valproate therapy and consider alternative treatment options. Annual reviews should not be delayed due to the pandemic.
No woman or girl should stop taking valproate without first discussing it with their doctor.
Guidance will be updated once these temporary recommendations are no longer considered necessary.
Call for reporting
Valproate medicines are black triangle medicines and all suspected adverse drug reactions should be reported to the MHRA.
Healthcare professionals, patients, and caregivers are asked to submit all suspected side effect reports using the Yellow Card scheme electronically using:
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the Yellow Card app; download now from the Apple App Store or Google Play Store
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through some clinical IT systems (EMIS/SystmOne/Vision/MiDatabank)
Article citation: Drug Safety Update volume 13, issue 10: May 2020: 2.