Valproate (Epilim) guidelines

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Background

Sodium Valproate (Epilim) is a medicine licensed in Ireland to treat epilepsy and bipolar disorder. If a woman becomes pregnant while taking Epilim, their baby is at risk of serious birth defects and developmental disorders. In 30-40% of cases where the child has been exposed to valproate in utero, the child will have serious developmental disorders. In 10% of cases, the child will have congenital malformations. The HSE estimate that up to 1,250 families have been impacted in these ways by exposure to valproate in pregnancy since the 1970s.

Preventative Measures

In February 2018, the European Medicines Agency (EMA) put in place measures to reduce the risk of exposure of babies to Epilim in the womb.

These measures are implemented in Ireland by the medicines regulator, the HPRA ,and include:

  • For women with epilepsy, Epilim must not be used in pregnancy unless there is no suitable alternative treatment.
  • In female patients from the time they become able to have children, Epilim must not be used unless the conditions of a Pregnancy Prevention Programme are met.

What are the main points of the Pregnancy Prevention Programme?

  • Prescribers must assess female patients for the potential of becoming pregnant, and involve the patient in evaluating her individual circumstances and supporting informed decision making,
  • Pregnancy tests must be carried out before starting and during treatment as needed,
  • Female patients must be informed about the risks of Epilim and what to do if planning a pregnancy or becomes pregnant
  • Effective contraception must be used throughout treatment and counselling on contraception provided
  • All female patients must be given the new patient information booklet and must sign an annual Risk Acknowledgement form acknowledging that they understand the risks and necessary precautions
  • Importantly, all female patients must have an annual review of treatment by a specialist. If you are not currently attending specialist services, please contact your GP for advice and guidance in order to schedule a specialist review.

PLEASE CONTACT YOUR HEALTHCARE TEAM IF YOU HAVE ANY CONCERNS. DO NOT STOP TAKING VALPROATE WITHOUT FIRST SPEAKING WITH YOUR PRESCRIBER.

Epilim Patient Information booklet (Jul 2020)

Please download the latest patient information booklet for women and girls, authorised by the HPRA in July 2020.

Resources for Healthcare Professionals

A range of resources are also available from the HPRA website for prescribers and pharmacists. These resources include a HCP Guide; posters, patient information cards and shelf-markers for pharmacists and the risk acknowledgement form for prescribers. Further details of the Pregnancy Prevention Programme for prescribers can be found here. Details of the PPP for pharmacists can be found here.

Other measures introduced in Ireland to reduce the risks associated with Epilim

  • Warnings on the outside of boxes including a pictogram.
  • Updated Package Insert Leaflet (for example, see PIL for Epilim 100mg tablets. PILs for other formulations can be found by searching Epilim at on the HPRA site)
  • Pack sizes have been made smaller to stop the practice of dispensing Epilim in plastic bags. The medication should be made available in its original packaging with the package insert leaflet included.
  • Patient information cards should be attached to these boxes.
  • Pharmacists also must follow further clear guidelines from the PSI (Pharmacy Regulator) regarding the dispencing of valproate.

Further Information