The HSE were advised by HSE National Clinical Advisor and Group Lead, Primary Care, David Hanlon to contact the 1,700 women of childbearing age who were prescribed Epilim while pregnant, as the drug can harm the foetus.

Although the HSE has not contacted these women directly, according to the Medical Independent, letters were issued to GPs and pharmacists in February and March 2018, advising them to identify women of childbearing potential who are/have been taking Sodium Valproate (Epilim), and to contact any identified patients directly.

Epilim is licensed in Ireland to treat epilepsy and bipolar disorder; however, studies have shown that taking Epilim while pregnant increases the risk of developmental disability to 30/40% and a 10% risk of birth defects.

In February this year, the European Medicines Agency (EMA) announced additional protective measures regarding valproate, as previous actions were deemed insufficient for risk management.

Foetal anti convulsant syndrome and Epilim (sodium valproate)

Foetal Anti Convulsant Syndrome (“FACS”) and Foetal Valproate Syndrome (FVS), covering a range of malformations, has been known about for decades, since before Epilim was licensed in Ireland.

It is only in 2014 that the European Medical Agency published its review of valproate medicines and the problems they can cause, and since then, doctors across the EU are advised not to prescribe valproate for epilepsy or bipolar disorder in pregnant women or women who can become pregnant, unless other treatments are ineffective or not tolerated.

There is a growing effort to raise awareness of the risks and of other medicines or approaches that can reduce them.

How is foetal anti-convulsant syndrome caused?

Foetal Anti-Convulsant Syndrome is caused when a mother uses anti-convulsant medication during pregnancy (also known as Anti-Epileptic Drugs, or AEDs: AEDs are not only used to treat epilepsy but are also used to treat pain, migraine, bipolar and other mental health conditions).

The FACS Forum, which includes the Disability Federation of Ireland, Epilepsy Ireland, the Organisation for Anti-Convulsant Syndrome Ireland, the Migraine Association of Ireland, Shine, the Genetic and Rare Disorders Organisation, and the Medical Research Charities Group, estimates that 400 infants may have been born here with foetal valproate syndrome.

FACS/FVS symtoms

Common issues for those suffering from FACS can include:

  • skeletal problems,
  • heart defects,
  • spinal bifida,
  • kidney damage.

Neurodevelopmental delays for children with FACS may include:

  • learning difficulties,
  • autism spectrum,
  • language delay;
  • mental health problems.

Talk to your doctor

Getting a diagnosis as soon as possible can assist with the effects of FACS/FVS, so if you have any questions in relation to your child and FACS/FVS, or if you are pregnant, please contact your doctor to discuss as soon as you can.

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How we can help

If you have been affected by a similar issue, the team at Coleman Legal LLP can advise you. Contact our team to discuss your case. Call 01 531 3800 or complete our contact form.

Our birth injury team advises parents affected by failures in maternity and neonatal care. Related information is available on our autism pages.

Time limits apply to bringing a claim, and they are not the same in every case. Our Statute of Limitations in Ireland guide explains how the period is counted.