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An estimated 400 children in Ireland affected by drug sodium valproate (epilim)

April 21, 2017, 16:30

An estimated 400 children in Ireland affected by drug sodium valproate (epilim).

FACS Forum calls on the Government to follow the French lead and investigate valproate use in Ireland .

21/04/2017: The FACS (Foetal Anti-Convulsant Syndrome) Forum, an umbrella of patient and disability organisations, is urging the government to undertake an investigation into the current and historical use of the drug sodium valproate (Epilim) in pregnant women, after a French report revealed over 4,000 children were born with malformations since 1967 following exposure to the drug in the womb.

Valproate has been licensed in Ireland since 1983 for use in epilepsy and bipolar disorder. The FACS Forum, which was established in 2013, estimates that the drug has affected at least 400 children with birth defects and developmental issues in Ireland.

The Forum, which consists of The Disability Federation of Ireland, Epilepsy Ireland, OACS Ireland, Medical Research Charities Group, Migraine Association of Ireland, Shine, and the Genetic and Rare Diseases Organisation have been working on this issue since the publication of the European Medicines Agency ruling on Sodium Valproate in 2014, which tightened restrictions on its use in women of childbearing potential.

Joan O’Donnell, Chairperson of the Forum said “The government urgently needs to identify the scale of the problem, to assess the often complex needs of the families affected, and to put in place appropriate pathways for the diagnosis and treatment of Fetal Anti-Convulsant Syndrome.

“To date, while the HPRA and HSE have taken some measures to improve awareness of the risks of valproate and to improve communication between patients and health professionals (e.g. producing information leaflets), the response has been unsatisfactory and there have been no efforts made to address the needs of families already affected.

“We would also call on the HPRA and the drug company to fulfill their promise from almost 12 months ago and immediately put warnings on the drug’s outer packaging to warn women who may still not be aware of the risks.

Over the past two years, Epilepsy Ireland has conducted a number of surveys of women taking the drug to assess the levels of risk awareness and the extent of communication taking place between patients and their medical teams. While these rates are improving, the most recent survey from November 2016 found that just over half of women (56%) had discussed the issue with their medical team and 1 in 5 were still not aware of the new restrictions in place since 2014.

Epilepsy Ireland CEO Peter Murphy said: “While valproate has proven to be an effective medication for preventing seizures, all women or parents of girls taking Valproate need to be aware of the risks involved. We urge them to speak to their medical team about this if they haven’t already to weigh up the pros and cons, but under no circumstances should they stop taking the drug without talking to their medical team.”


For more information contact:

Joan O’Donnell, Chairperson of FACS Forum on 086 383458 /

Epilepsy Ireland CEO Peter Murphy, 086 810 8600

Note to Editor:

FACS Forum Ireland came together in 2013 to highlight birth defects suffered by pregnant women prescribed medication containing sodium valproate. Several dozens of families are represented as well as Disability Federation Ireland (DFI), Epilepsy Ireland (EI) Genetic and Rare Diseases Organisation (GRDO), Medical Research Charities Group (MRCG), Organisation for Anti-Convulsant Syndromes Ireland (OACS Ireland), Shine, Migraine Association of Ireland

Epilepsy Ireland is the national organisation supporting and representing people with epilepsy, their families and carers. Established in 1966, the charity today provides a wide range of support and information services from head office in Dublin and from nine locations around the country. The charity also provides training programmes for both health professionals and for young adults with epilepsy; actively works to improve public understanding of epilepsy and funds high quality Irish research into the condition.

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Conor Culkin

Communications Officer

01 455 7500

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