A CHAIRPERSON HAS been appointed to an inquiry examining the historical use of sodium valproate, an antiepileptic drug which can cause serious birth defects if used during pregnancy.

Minister for Health Stephen Donnelly today announced the appointment of barrister and mediator Bríd O’Flaherty as chair of the inquiry.

The inquiry into the historical licensing and use of the drug was approved by Cabinet in July 2023, almost three years after Donnelly committed to holding a probe into the drug. 

In January of this year, the Organisation for Anticonvulsant Syndromes Ireland patient group expressed disappointment at the slow pace in the government’s appointment of a chair to the inquiry. 

With the chair appointed, the inquiry can officially begin.

The non-statutory inquiry will document the evolution of the drug’s regulation in Ireland, practices and controls in relation to prescribing and dispensing, and the timeline of developments in scientific knowledge about the potential impact of the drug on fetal development.

Sodium valproate can cause serious birth defects and developmental disorders to an infant if taken during pregnancy and women have been advised against using it unless no other treatment is possible.

The drug was prescribed in Ireland and elsewhere for decades after the danger was discovered and many countries are now investigating its use.

Today, the Health Products Regulatory Authority (HPRA) states that the drug can cause birth defects and problems with the development and learning of the child if their mother takes it during pregnancy.

Children exposed to the drug while in the womb are at a high risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases).

Symptoms of fetal valproate syndrome (FVS) vary, but can include characteristic facial features, spina bifida, congenital heart defects, cleft lip and/or cleft palate, genital abnormalities, skeletal abnormalities and developmental delay. 

‘Independent and balanced process’

Speaking today, Donnelly said that he was “delighted” to honour his commitment to people negatively impacted by the drug.

“I know Bríd O’Flaherty will lead an independent and balanced process that rigorously examines the use of sodium valproate in Ireland, providing us with valuable information and insights to inform our next steps, and putting patients and families at the core of her consideration,” he said.

Sodium valproate’s risk to infants has been made public in recent years, but campaigners in the UK found documents in the National Archives that indicated health regulators were aware of the risk as far back as 1973 but chose not to warn patients, saying it “could give rise to fruitless anxiety”.

A HSE report published in 2018 estimated that 1,250 children have been affected by valproate since 1975 in Ireland.

In 2021, an investigation by Noteworthy found that around 3,000 Irish children were potentially harmed by exposure to the drug in the womb.

Earlier this year, doctors in Ireland were told to also inform men of the potential risks that taking sodium valproate can have on their future children before prescribing it to them.

This was after a study found that there is a potential increased risk of neurodevelopmental disorders in children born to men treated with the drug during the three months before conception.

Donnelly said: “It’s important to note that sodium valproate is an effective medication and continues to be an essential part of the treatment plan for some patients.

“It is therefore vital that people currently taking sodium valproate do not make changes to their treatment without first discussing their concerns with their doctor.”

Once the inquiry is established, O’Flaherty will publicise information about how people can take part, including via an accessible website with clear routes of contact, Donnelly’s statement said. 

Hope inquiry will ‘answer longstanding questions’

In a statement, the Organisation Anticonvulsant Syndromes Ireland (OACS Ireland) welcomed today’s announcement and said it looks forward to working constructively with O’Flaherty.

Speaking previously regarding the enquiry, Karen Keely, Chairperson of OACS Ireland said: “We sincerely hope that this inquiry will, through transparency and public interest, act as a vehicle to finally answer our longstanding questions and give a voice to those who have been harmed, some catastrophically over the years.”

Families are trusting that the process, under the guidance of an independent chair, will strike at the heart of key issues such as how and why this was allowed to happen; why it took so long for effective preventative regulatory steps to be put in place; and whether the steps taken by the State over time were in line with the progression of scientific knowledge.

A small number of OACS Ireland’s members had an opportunity to briefly meet
the newly-appointed chairperson. They said a further, more substantive meeting is planned.

The group also noted that there is “a significant job of work to be done” before the inquiry commences.

“We are ready to work with the Chairperson to ensure that appropriate procedures, resources and logistical arrangements are put in place to ensure maximum participation of families affected by sodium valproate with the inquiry.”

With reporting from Jane Moore