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Non-Statutory Inquiry approved by Cabinet into Sodium Valproate use
Coleman Legal LLP
Jul 14, 2023

Minister for Health, Stephen Donnelly, has today announced that there will be a non-statutory inquiry into the historical prescription of sodium valproate to women while pregnant. 

Sodium Valproate, sold under the brand name Epilim, is an oral medication prescribed to sufferers of epilepsy. Minister Donnelly had in November 2020, committed to an inquiry into the use of sodium valproate in Ireland.

The drug is now known to cause developmental disorders and severe birth defects in children whose mothers it was prescribed to during pregnancy. 

The Health Products Regulatory Authority (HPRA) now states that the drug poses a serious threat to pregnant women’s children. The drug was prescribed to women in Ireland for several years after this risk was identified. 

Studies have shown that there is a severe risk in up to 30-40% of cases of severe developmental disorders for children exposed to the drug while in the womb. There are also congenital malformations in 10% of children whose mothers were treated with the drug while pregnant.

In 2018, the HSE published a report estimating that 1,250 children had been harmed due to exposure to Sodium Valproate in the womb since 1975. 

Earlier this year, the NHS in the UK published a review into the use of the drug and criticised the failures across the board to safeguard patient safety. It also highlighted the failure to act on the risks posed by the drug. 

In 2022, a French court permitted families affected by the issue to join a class action against the drug manufacturers.

While families affected welcome the move, they are disappointed with the non-statutory nature of the Inquiry, having favored one of a Statutory nature. 

Those affected so devastatingly by the effects of the prescription of Sodium Valproate during pregnancy await answers as to how this situation was allowed to occur, and also as to why effective preventative regulatory steps took so long to come into effect.

If you or your child have been affected by the prescribing of Sodium Valproate (Epilim) during pregnancy, please don’t hesitate to contact our Medical Negligence team at Coleman Legal LLP to discuss what options may be available to you. 

Keith Rolls Partner Coleman Legal LLP

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