In November 2020, the Minister for Health, Mr Stephen Donnelly, announced that an inquiry would take place into the historical licensing and use of the epilepsy drug Sodium Valproate (also known as “Epilim”). The focus of the inquiry will be on children who were exposed to Sodium Valproate in the womb.
What is Sodium Valproate?
Sodium Valproate is a commonly prescribed drug used to control epileptic seizures. However, studies have shown that the drug can have catastrophic effects for pregnant women and their unborn babies. For example, in 30-40% of cases, a baby is more likely to be born with neurodevelopmental disabilities (such as autism, memory issues or learning difficulties) if the mother takes the drug while pregnant. There is also evidence to suggest that some babies are more likely to be born with congenital malformations (such as spina bifida or cleft lip / palate) if the drug is taken during pregnancy.
Why has the Inquiry Commenced?
The drug was first licensed in 1975 in Ireland, but there has since been emerging evidence that it can have detrimental impacts on unborn children. The HSE published a report in 2018 confirming that an estimated 1,250 children have been exposed to Sodium Valproate since the 1970s, albeit pregnant mothers were advised to continue taking the drug.
Therefore, OACS (“Organisation Anticonvulsant Syndromes”) Ireland and affected families are now calling for answers as to why they were not informed of the dangerous side effects and why they were encouraged to continue taking the drug.
What are the Recent Developments?
A non-statutory inquiry was approved by the Cabinet in July 2023. Karen Keely, founder of OACS Ireland, recently met with Department of Health officials to discuss the inquiry, but this meeting proved futile. She said that “there is no person named for the chair yet, and there is no date for that as of yet”. Ms. Keely added that she wishes for the inquiry to run “smoothly and quickly” for the affected families, but it is also important that the Department of Health appoints the right person to chair the inquiry.
Conclusion
The Department of Health has recently stated that “work is actively ongoing” to appoint a chair to the inquiry, but, to date, no progress has been made. Therefore, it is hoped that the Department will accelerate the inquiry in 2024 and will provide the affected families with the answers that they deserve.
Further Information
For further advice or if you have been affected by these recent developments, please contact Avril Scally or Nicholas Moore in our award-winning Medical Negligence Team.
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