Families affected by prescribing of sodium valproate in pregnancy call for inquiry

It is now accepted babies exposed to valproate in the womb have a 10% risk of birth defects and a 30%-40% risk of neuro-developmental disabilities which can be permanent. Picture: PA Photo/thinkstockphotos

Families affected by the prescribing of sodium valproate in pregnancy have called for a long-promised inquiry to be set up as soon as possible.

This comes as the British health regulator advises no one under the age of 55, male or female, should be prescribed valproate without sign-off by two independent consultants. This is because of the serious risk to babies in the womb and risks for male fertility. 

Valproate, commonly sold under the brand name Epilim, is an ingredient in medication used to treat epilepsy, bipolar disorder, and other conditions. However, since the 1980s evidence has been emerging it can lead to life-changing disabilities for babies.

Health Minister Stephen Donnelly committed in November 2020 to establish an inquiry into the historical licensing and use of sodium valproate. Terms of reference were accepted last month by families.

Support group Organisation Anticonvulsant Syndromes (OACS) Ireland founder Karen Keely said: “From our most recent meeting with department officials, we understand that the Department intends to bring proposals for the inquiry to Cabinet before Christmas.” 

She said: “We look forward to a decision being taken in the coming weeks.” 

However, a department spokesman said work continues, adding “a memo for Government will be brought as soon as this work is completed”. 

It is now accepted babies exposed to valproate in the womb have a 10% risk of birth defects and a 30%-40% risk of neuro-developmental disabilities which can be permanent.

This has left families struggling to raise children with life-changing disabilities. Earlier this month the High Court approved a €12m settlement for a teenage boy with autism and foetal valproate syndrome (FVS).

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Ms Keely said: “OACS Ireland still wait for a full disability pathway to encompass the needs for children harmed by sodium valproate (Epilim) right now all families have is a one-page document called the community pathway which is clearly not working.” 

The decision by the British medicines regulator on Monday followed a data review and advice from the Commission on Human Medicines.

In addition to advice linked to pregnancy, they recommended: “The possible risk of impaired fertility in males has been in the product information since 2011 and should be discussed between patient and doctor as part of the informed consent process.” 

It comes after an English coroner linked sodium valproate for the first time to a death, the House of Commons heard. Jake Alcroft, aged 21, died in April.

Chair of the Women and Equalities Committee at Westminster Caroline Noakes said: “The coroner listed foetal valproate syndrome as a contributing factor to his death because of the physical damage done to Jake as an exposed baby.”