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Government approval for inquiry into historical use of sodium valproate

By Irish Pharmacist - 01st Aug 2023

Minister for Health Stephen Donnelly has secured Government approval to progress a non-statutory inquiry into the historical licensing and use of sodium valproate in women of child-bearing potential in the State. Minister Donnelly had committed in late 2020 to the establishment of an inquiry.

While valproate is an effective and essential treatment for some patients, valproate-containing medicines can cause birth defects and developmental disorders in children whose mothers take such medicines during pregnancy.

According to the Department: “The purpose of this inquiry is to provide a voice to persons with a diagnosis of foetal valproate spectrum disorder, their mothers, and other family members. The inquiry will also seek to document the evolution of sodium valproate regulation and the practices around the control of this product.”

The Chair of this inquiry will be tasked with assessing the health service’s current capacity to respond to safety issues relating to use of anti-seizure medications in women of child-bearing potential.

Minister Donnelly said: “There is work to be done before the non-statutory inquiry can commence, but this is an important milestone, and my officials will now work to bring this forward.” OACS Ireland (Organisation Anticonvulsant Syndromes Ireland) and Epilepsy Ireland welcomed the approval from cabinet to establish an inquiry.

Ms Karen Keely, Chairperson of OACS Ireland, said: “From the outset, OACS Ireland members favoured the establishment of a statutory inquiry as being the most appropriate vehicle to fully investigate the history of the licensing and prescribing of sodium valproate in Ireland. However, we were left in no doubt during our prolonged negotiations that the terms of reference agreed by cabinet today were the only terms on offer. Our members reluctantly agreed to proceed with a non- statutory inquiry.”

She added: “While the structure is not what we would have chosen at the beginning of this process, we sincerely hope that this inquiry will, through transparency and public interest, act as a vehicle to finally answer our long-standing questions and give a voice to those who have been harmed, some catastrophically over the years.”

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