LAST UPDATE | 11 Jul 2023
HEALTH MINISTER STEPHEN DONNELLY has secured Cabinet approval for a non-statutory inquiry into the historical use of sodium valproate, prescribed as an anti-epilepsy drug to women while pregnant.
Sodium valproate is an oral medication, sold in Ireland under the brand name Epilim, which has been licensed and prescribed worldwide since the 1970s, primarily for the treatment of epilepsy.
The drug has been licensed in Ireland since 1975.
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.
Today Government approved my request to establish an inquiry into the use of sodium valproate in Ireland. My thanks to @oacsireland @epilepsyireland and all stakeholders. A step forward for the women and families affected. https://t.co/pg4vZ8Nn6w
— Stephen Donnelly (@DonnellyStephen) July 11, 2023
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 Noteworthy found that around 3,000 Irish children were potentially harmed by exposure to the drug in the womb.
In November 2020, Donnelly committed to holding an inquiry into the historical licencing and use of sodium valproate in Ireland.
It came months after a two-year inquiry in the UK published a review that criticised failures by manufacturers, regulators, clinicians and policymakers to uphold patient safety and to take action on the risks the drug poses.
A similar inquiry was conducted in France, and last year, a French court allowed affected families to join a class action against manufacturer Sanofi.
Today, Donnelly secured Government approval to progress an inquiry into the historical licensing and use of the drug in Ireland.
“The purpose of this inquiry is to provide a voice to persons with a diagnosis of foetal valproate spectrum disorder (FVS), their mothers and other family members,” a statement from the Department of Health said.
“The inquiry will also seek to document the evolution of sodium valproate regulation and the practices around the control of this product.”
Donnelly said: “When I met with the patient groups involved with this issue, I supported their call for an inquiry, and I am very pleased to be able to progress this. This inquiry will be designed to give a voice to patients and their families while looking at the use of sodium valproate in Ireland since it was first licensed.
“There is work to be done before the non-statutory inquiry can commence, but this is an important milestone, and my officials will now work to bring this forward,” he added.
OACS Ireland and Epilepsy Ireland have both welcomed the move to establish the inquiry.
Karen Keely, Chairperson of OACS Ireland said: “From the outset, OACS Ireland members favoured the establishment of a Statutory Inquiry as being the most appropriate vehicle to fully investigate the history of the licencing and prescribing of Sodium Valproate in Ireland.
“However, we were left in no doubt during our prolonged negotiations that the terms of reference agreed by Cabinet today were the only terms on offer. Our members reluctantly agreed to proceed with a non-statutory inquiry,” she said.
The last three years have been marked by lengthy and frustrating delays in getting the inquiry established with extensive discussions on the form of the inquiry and its terms of reference.
Keely said that while the structure is not what the group would have chosen at the beginning of this process, they sincerely hope that this inquiry will, “through transparency and public interest, act as a vehicle to finally answer our long-standing 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.
“However, we are under no illusions about the non-statutory nature of the inquiry and recognise that we are at the end of a phase of our campaigning, rather than the end of the campaign.”
She added that there is still a lot of work to be done and looks forward to working with the Chair and the Department of Health to ensure that supports are put in place to facilitate maximum participation of families affected by the drug and ensure an effective communications campaign is put in place to seek out affected families.
“Overall, today is an important day for all the families in Ireland whose children have been left with devastating birth defects and neurodevelopmental delay as a direct result of their mothers taking sodium valproate during pregnancy.
“It has taken over a decade of our lives to get to this stage and we are pleased to be moving forward at long last.”
Epilepsy Ireland CEO Peter Murphy said the decision paves the way for the State to begin the process of understanding the history of sodium valproate and the impact that exposure to the drug has had for an estimated 1,250 families in Ireland.
“Other European countries including the UK and France have already taken action on this issue, and we hope that Irish families will soon have their voices heard, and in time, the answers they rightly deserve,” he said.
“By documenting the regulation and practices around the prescribing and dispensing of sodium valproate, alongside a thorough review of the development of scientific data over time, a clearer historical picture will emerge not just for those impacted but to inform recommendations to ensure that this never happens again.
“It is vital that public trust in how our medicines is regulated and prescribed is maintained. It is equally vital that we do all possible to ensure the safety of women who continue to be prescribed the medication to this day, as well as their future children”.
In March, two medical negligence solicitors called called for a redress scheme to be established for children who were born with birth defects as a result of their mothers being prescribed an anti-epilepsy drug while pregnant.
Separately today, the health minister will also taken the next step in building a new National Maternity Hospital on the St Vincent’s Hospital site.
Donnelly is seeking Cabinet approval today to proceed to tender for the hospital at Elm Park.
It’s proposed to co-locate the new hospital with the adult teaching hospital as part of a modern campus approach to healthcare with the range of medical entities located and operating in close proximity to each other.
The proposed new NMH is expected to provide a range of new facilities for new and expanded maternity and gynaecology services, as well as 80 more beds than the current capacity at Holles Street.
Additional reporting by Jane Moore
To embed this post, copy the code below on your site
have your say