Minister for Health announces Chair of inquiry into historical use of sodium valproate in certain groups of women
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From: Department of Health
- Published on: 26 June 2024
- Last updated on: 24 October 2024
Minister for Health Stephen Donnelly has announced the appointment of Bríd O’Flaherty BL as Chair of the Inquiry into the historical licensing and use of sodium valproate in women of child-bearing potential in the State.
While sodium valproate is an effective and essential treatment for some patients, valproate-containing medicines can cause birth defects, neuro-developmental disorders and autism in children whose mothers take such medicines during pregnancy.
The non-statutory inquiry will document the evolution of sodium valproate regulation in Ireland, the 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 foetal development.
It has been set up to give a voice to those affected by a diagnosis of foetal valproate spectrum disorder (FVSD) and will assess the adequacy of services and supports currently in place for patients and their caregivers. The inquiry will also consider the health service’s capacity to address safety issues relating to the use of sodium valproate in some groups of women and will make recommendations as deemed necessary.
Minister Donnelly said:
“Today marks a significant step for those who have for years spoken out as a voice for their loved ones, for those who cannot use their own voices as a result of FVSD.
"It was my privilege today to welcome advocates, patients and their families to the Department of Health and I want to warmly congratulate them on their tireless efforts to ensure that lessons are learned from their lived experience, for the benefit of patients and for future generations.
“I’m delighted to be able to honour the commitment I made to them when we first met, beginning with the appointment of the chair of the inquiry.
“I know Brid 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.”
Minister Donnelly added:
“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, the Chair will publicise information about how people can take part, including via an accessible website with clear routes of contact.
Notes
The purpose of this Inquiry is to:
- provide a voice to persons with a diagnosis of foetal valproate spectrum disorder (FVSD), or progressing through the diagnostic pathway, their mothers and other family members
- document the regulation of sodium valproate in the State from initial licensing to the present day and the corresponding practices and controls in place relating to the prescribing and dispensing of this product to women of child-bearing potential throughout this time
- develop a timeline of significant developments in the scientific knowledge relating to the teratogenicity (the ability of a substance to cause an abnormality following foetal exposure during pregnancy) of sodium valproate
- assess the Irish health service’s current capacity to respond, disseminate and implement measures that address safety issues relating to use of sodium valproate in women of child-bearing potential, and provide recommendations regarding same, with consideration of relevance to other anti-seizure medications (ASMs)
- assess the adequacy of services and supports currently provided to those diagnosed with FVSD and their caregivers and provide recommendations regarding same if identified
- make recommendations as appropriate to the Minister for Health
Bríd O'Flaherty
A qualified Barrister and Mediator, Bríd has extensive medical negligence practice and is a versatile advocate in dispute resolution and mediation proceedings across a diverse range of practice areas, possessing strong research and analysis expertise relating to complex legal issues. Throughout her career she has worked with marginalised and vulnerable groups and people with disabilities.