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 the the Medical Independent, letters were issued to GPs and pharmacists in FEbruary and March 2018, advising them to identify women of child-bearing potential who are/have been taking Sodium Valproate (Epilim), and to contact any identifed patients directly. Epilim is licensed in Ireland to treat epilepsy and bipolar disorder, however studies have shown that taking Epilim while pregnant increases risks 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 around valproate, as previous actions were not deemed sufficient in terms of 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 their 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 spread awareness of the risks and the possibility of other medicines or approaches to reduce those risks.  [more info here]

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, bi-polar 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.

Relevant news

• Irish Examiner 29/05/2018 – ‘HSE must contact women who took epilepsy drug that endangers foetus’
• The Guardian – Birth defect risks of sodium valproate ‘known 40 years ago’
• RTÉ News – EMA hearing over use of epilepsy drug for pregnant women