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MHRA update valproate Pregnancy Prevention information

Epilim▼, for Epilepsy

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.

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Feature

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:
  • epilepsy
  • acute mania
  • 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%.

Sources
MHRA website for Pregnancy Prevention Programme
Contains public sector information licensed under the Open Government Licence v3.0.
Accessed 17/04/19
Links available in full article

LINK to MHRA information on valproate Pregnancy Prevention Programme

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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