MHRA update valproate Pregnancy Prevention information
Epilim▼, for Epilepsy
Wednesday 17th April 2019 | Source MHRA | Type Patient Safety Update
The Medicines and Healthcare products Regulatory Agency (MHRA) have published updates for valproate medicines and serious harms in pregnancy. The updates include a new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme.
Ongoing patient survey data suggest that more effort is needed by clinicians to achieve full and timely compliance with the valproate Pregnancy Prevention Programme and meet the goal to rapidly reduce and eventually eliminate the harms of valproate in pregnancy in view of its serious effect in causing birth defects.
The MHRA have updated the Annual Risk Acknowledgement Form, which should be used during annual specialist review of all women and girls of childbearing potential on valproate medicines (irrespective of indication). Specialists should comply with guidance given on the form if they consider the patient is not at risk of pregnancy, including the need for regular review in case her risk status changes.
You can follow developments with valproate by using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.
Valproate refers to 3 types of valproate available in the UK to which this advice applies:
sodium valproate which may be given as a generic or one of the following brands - Epival - Epilim - Episenta
valproic acid - in combination with sodium valproate generic or as the brand - Epilim Chrono - Epilim Chronosphere
valproate semisodium - as a generic or the brand - Depakote
Both valproate semisodium and sodium valproate are converted in the body to valproic acid, which is the active ingredient.
The UK licence for the 3 formulations of valproate differ depending on the individual product. At the time of publication (March 2019), licensed indications for valproate are the treatment of:
continuation treatment in people who have had mania that has responded to treatment with valproate.
Evidence shows that 1 in 10 babies (10%) exposed to valproate in pregnancy are born with a congenital malformation (birth defect) – for the general population, the risk is about 2–3%.
MHRA website for Pregnancy Prevention Programme
Contains public sector information licensed under the Open Government Licence v3.0.
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