Investigation Launched into Prescribing of Anti-Epilepsy Drug

An inquiry has started to examine the historical prescribing of an anti-epilepsy medication that may lead to birth defects if used during pregnancy. The investigation, focusing on sodium valproate, aims to understand its usage, safety, and regulations over the years. Over 1,000 children in Ireland have reportedly been affected since the 1970s.

Jul 22, 2025 - 12:32
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Investigation Launched into Prescribing of Anti-Epilepsy Drug

An inquiry has started to look into the historical prescribing of an anti-epilepsy drug that can lead to birth defects if used during pregnancy. The inquiry, focusing on sodium valproate (sold as Epilim), is expected to last 12 to 18 months. It's estimated that over 1,000 children in Ireland have been affected since the 1970s.

Chaired by barrister Bríd O'Flaherty, the inquiry will be divided into various phases. The first phase will review the drug's usage history, safety information, and regulations. The Department of Health stated that the inquiry can request documents from stakeholders and must document any refusals.

The second phase will involve private oral statements from affected families. Subsequent phases will assess the health services' ability to address safety concerns related to anti-seizure medications in women. Data regulations were recently passed in the Dáil and Seanad to support this.

Families have long campaigned for this inquiry, and its commencement has been welcomed. The Department of Health has emphasized that while sodium valproate is effective for some, patients should consult their doctors before making any treatment changes. The drug can lead to birth defects, neurodevelopmental disorders, and autism in children of mothers who take it during pregnancy.

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