Inquiry begins into historical use of anti-epileptic drug and effects on pregnant women

Irish Times

7 days ago

The historical licensing and use of the anti-epileptic drug sodium valproate for women of childbearing age will be examined as part of an inquiry that started its work on Tuesday.
Mothers of children diagnosed with foetal valproate spectrum disorder (FVSD)
have long called for a public inquiry to investigate why they were not warned about the risks of taking the drug while pregnant
.
FVSD is caused by exposure in the womb to valproic acid, which is the key ingredient in sodium valproate, better known in Ireland as Epilim.
An Irish Medical Journal study published in 2021 said diagnosing the condition was 'difficult' due to the lack of any specific diagnostic test or biomarker.
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However, it said dysmorphic facial features, neural tube defects, congenital heart disease and cleft lip were among the most commonly associated characteristics.
The study noted that Irish public health data suggested 3,126 babies were potentially exposed to sodium valproate before birth between 1975 and 2015.
Minister for Health Jennifer Carroll MacNeill said the inquiry would give people directly affected by sodium valproate an 'opportunity to have their voices heard'. She welcomed the commencement of the inquiry, which was announced last year by her predecessor, Stephen Donnelly.
She said she recently met the Organisation Anticonvulsant Syndromes Ireland (OACS Ireland), a campaign group dedicated to supporting and advocating for families affected by foetal anticonvulsant syndrome.
'I know this is an important day for them and the families they represent,' Ms Carroll MacNeill said.
'I have every confidence that the chair will conduct an independent and fair inquiry and finally get answers for those affected and their families.'
The inquiry, involving three distinct phases, is chaired by barrister Bríd O'Flaherty. The Department of Health said it envisaged she would spend 12 to 18 months conducting an 'independent, fair and rigorous process'.
The first phase will establish a timeline for the use of sodium valproate in women of childbearing potential in the State, including information on regulation, prescribing, dispensing and safety information issued.
The inquiry will document the evolution of the drug's regulation and practices around its control.
The second phase will focus on oral statements from people diagnosed with FVSD, their mothers and other family members.
The final strand will assess the health service's capacity to respond to safety issues related to the use of anti-seizure medications in women of child-bearing potential.