The inquiry will have three strands and invite those impacted by sodium valproate to give oral statements from September.
A LONG-AWAITED inquiry into an antiepileptic drug that can cause serious birth defects if used during pregnancy has finally gotten underway, nearly five years after the Government committed to holding one.
The non-statutory inquiry into the historical licensing and use of sodium valproate will have three strands, with statements from those affected by the drug expected to be taken from September.
Health Minister Jennifer Carroll MacNeill has welcomed the commencement, saying that it “will give those directly affected by sodium valproate an opportunity to have their voices heard”.
The inquiry was approved by Cabinet in July 2023, almost three years after the then-health minister Stephen Donnelly committed to holding a probe into the drug.
Barrister and mediator Bríd Flaherty was announced as the chairperson of the non-statutory inquiry in June 2024, with Donnelly saying at the time that he intended to get it up and running “in a matter of weeks“, but this did not take place.
The delay in the commencement of the inquiry was caused due to the fact that the data regulations had yet to be finalised.
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 years 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.
The drug’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 The Journal Investigates found that around 3,000 Irish children were potentially harmed by exposure to the drug in the womb.
Last January, doctors began informing men of the potential risks that taking sodium valproate can have on their future children before prescribing it to them following precautionary measures recommended by the European Medicines Agency.
Inquiry
The Department of Health said the inquiry will have three strands.
The first strand will be the review phase, which will establish a timeline for the use of sodium valproate in Ireland “in women of childbearing potential including information on regulation, prescribing, dispensing and safety information issued”.
The inquiry will seek to document the evolution of the regulation of the drug and the practices around the control of it.
The Department said the inquiry “will have responsibility to request documentation and submissions from a range of stakeholders”, and the chair will record “difficulties encountered where such requests are refused as part of their reporting function”.
The second strand of the inquiry will seek oral statements from anyone impacted by the use of the drug, including people diagnosed with Foetal Valproate Spectrum Disorder (FVSD), their mothers and other family members who may wish to participate.
This is anticipated to begin in September. Anyone who wishes to take part in this strand of the inquiry can register their interest on its website. These sessions will be held in private, and other stakeholders may also be invited to provide oral statements in separate sessions.
The third strand will focus on assessing the health service’s current capacity to respond to safety issues “related to use of anti-seizure medications (ASMs) in women of childbearing potential”.
This will involve an assessment of the current systems in place to respond, disseminate and implement measures that address these potential safety issues, the development of other recommendations regarding current control systems for sodium valproate and other ASMs, and the services and supports for those impacted by sodium valproate.
The Department said the results of this assessment will inform future service development.
A communications campaign will be launched in the coming weeks to raise public awareness and support engagement with the inquiry.
‘The real work starts now’
Last month, when the inquiry had yet to commence, the Organisation for Anticonvulsant Syndromes (OACS) Ireland group, which supports families that have been impacted by the drug, told The Journal that it was seeking a meeting with the Minister for Health to discuss the status of the inquiry.
Today, Carroll MacNeill said she was “grateful” to meet with OACS Ireland recently “and I know this is an important day for them and the families they represent”.
“I have every confidence that the Chair will conduct an independent and fair Inquiry and finally get answers for those affected and their families,” she said.
OACS Ireland said they met with the Minister on 14 July. The data regulations, which needed to be approved before the inquiry could commence, passed through the Oireachtas last week and were formally signed by the Minister on Monday.
In a statement, chair of OACS Ireland Karen Keely, whose three adult sons have been affected by exposure to sodium valproate, said: “The real work starts now.
“The Inquiry will draw a spotlight on a public health issue which, whilst life-changing, is perhaps not as well known or understood by the public as other public health issues,” Keely said.
Solicitor Ciara McPhillips, who represents OACS Ireland within the inquiry process, said: “Together with OACS, I look forward to working with all stakeholders under the stewardship of the Chair to ensure those affected understand how it arose that women and mothers were prescribed a medication, which whilst very effective in preventing seizures, was so devastatingly detrimental to their children – many of whom will never live independent lives.”
