It is one year since the non-statutory inquiry into the use of sodium valproate in Ireland began<\/p>\n
The final report of a review into the historical use of an epilepsy drug by mothers during pregnancy that led to a life-long disorder in their children will be completed by next April, the Department of Health has said.<\/p>\n
It is one year since the non-statutory inquiry into the use of sodium valproate in Ireland began. Trading under the name Epilim in Ireland, the drug is regularly prescribed here for the treatment of epilepsy and bipolar disorder.<\/p>\n
However, children exposed to sodium valproate in the womb are at a high risk of serious developmental disorders (in up to 40 per cent of cases) and congenital malformations.<\/p>\n
Chaired by Br\u00edd O\u2019Flaherty BL, the inquiry will review how the drug has been prescribed in Ireland, as well as the timeline of scientific knowledge about the product\u2019s effects on foetal development. It will also look into the capacity of Ireland\u2019s health service to address safety concerns around the treatment and make recommendations where necessary.<\/p>\n
An interim report was completed and issued to Minister for Health Jennifer Carroll MacNeill in January this year. However, her Department has refused to publish the interim report before the final review has ended.<\/p>\n
In a statement, a Department of Health spokesperson told IMT: \u201cThe interim report will be published alongside the final report, supporting transparency while avoiding any potential impact on the ongoing work of the inquiry.\u201d<\/p>\n
They added that phase one hearings \u2013 in which the inquiry has created a timeline for the use of sodium valproate among women of child-bearing age \u2013 was completed in June.<\/p>\n
Preparations for phase two \u2013 which involves oral statements to be given by individuals diagnosed with Foetal Valproate Spectrum Disorder (FVSD) and their families \u2013 are currently underway. FVSD \u2013 the name for the collection of symptoms that can be caused by prenatal exposure to sodium valproate \u2013 can include physical malformations, distinctive facial features and lifelong neurodevelopmental difficulties.<\/p>\n
Families affected by the disorder have long been campaigning for an Inquiry to investigate how sodium valproate was regulated and prescribed in Ireland. While the Government announced in July 2023 that a non-statutory review would take place, it was a further two years before the Inquiry got underway. The founder of campaign group OACS (Organisation Anti-convulsant Syndromes) Ireland has called for every affected person to immediately be given a medical card and have a full care pathway in place for them.<\/p>\n
Karen Keely has three boys with FVSD. While a long-term user of sodium valproate to control her seizures, it was only in 2001 \u2013 two years after the birth of her third boy \u2013 that she was told of the link between the medication and neurodevelopmental disorders.<\/p>\n
\u201cIn relation to my oldest son I wasn\u2019t informed off any risks at all on him,\u201d she told IMT. \u201cMy other two boys, I was only told of the risk of spina bifida and cleft palate.\u201d<\/p>\n