Inquiry Launched into historical Use of Anti-Epileptic Drug Sodium valproate
An inquiry has commenced it’s work to examine the historical licensing and use of the anti-epileptic drug sodium valproate,particularly for women of childbearing age. This investigation comes after years of advocacy from mothers whose children where diagnosed with foetal valproate spectrum disorder (FVSD).
FVSD is a condition resulting from prenatal exposure to valproic acid, the primary component of sodium valproate, widely known in Ireland as Epilim. Mothers have long demanded a public inquiry to understand why adequate warnings about the drug’s risks during pregnancy were not provided.
A 2021 Irish Medical Journal study highlighted the diagnostic challenges of FVSD, noting the absence of a specific diagnostic test or biomarker. However, the study identified common characteristics associated with the condition, including dysmorphic facial features, neural tube defects, congenital heart disease, and cleft lip. Public health data from Ireland suggests that between 1975 and 2015, approximately 3,126 babies may have been exposed to sodium valproate before birth.
Minister for Health Jennifer Carroll MacNeill stated that the inquiry will provide a crucial platform for individuals directly affected by sodium valproate to share their experiences. She expressed her support for the inquiry, which was initiated last year by her predecessor, Stephen Donnelly. Minister Carroll MacNeill recently met with the Organisation Anticonvulsant Syndromes Ireland (OACS Ireland), a group supporting families impacted by foetal anticonvulsant syndrome.
“I no this is an meaningful day for them and the families they represent,” Minister Carroll MacNeill commented. “I have every confidence that the chair will conduct an autonomous and fair inquiry and finally get answers for those affected and their families.”
The inquiry, lead by barrister Bríd O’Flaherty, will proceed in three distinct phases and is expected to take between 12 to 18 months to complete. The Department of Health anticipates a thorough and impartial process.
The initial phase will focus on establishing a thorough timeline of sodium valproate’s use among women of childbearing potential in Ireland, encompassing details on its regulation, prescribing practices, dispensing, and the dissemination of safety data. This phase will also document the evolution of the drug’s regulatory framework and control measures.
The second phase is dedicated to hearing oral testimonies from individuals diagnosed with FVSD,their mothers,and other family members. the final phase will evaluate the healthcare system’s capacity to address safety concerns related to the use of anti-seizure medications in women of childbearing potential.