Sodium valproate is an epilepsy medicine commonly sold under the name Epilim. It was known since its availability in the 1970s that it may cause birth defects if used in pregnancy yet for decades many women across the world were prescribed this drug without being warned of this risk by their doctors.
This investigation was part-funded through crowdfunding (€580 of the proposed €1,500). However, with the announcement of the inquiry into valproate late last year, we consulted funders about a change in scope. This funding, in addition to some support from our general fund, allowed us to conduct a project focused on the lack of progress in implementing some key recommendations on valproate.
A HSE report that was published in 2019 found that over 3,000 babies were potentially exposed to valproate in Ireland between 1975 and 2015. From this, it is estimated between 153 and 341 children will have experienced a major congenital malformation and up to 1,250 children will have experienced some form of neurodevelopmental delay.
Simon Harris, then Health Minister, said in 2018 that he was “considering” an investigation into what happened in the past to see if the “State did everything appropriate” but this probe did not materialise. Two years later, in November 2020, Health Minister Stephen Donnelly announced that an inquiry will take place. The structure of that inquiry is being discussed.
In France, a compensation scheme was recently set up for children born to a mother who has taken sodium valproate or one of its derivatives. No such scheme exists in Ireland.
Surveys completed in the UK found that around 20% of women taking valproate were unaware of the risks in pregnancy. In Ireland, a small survey reported that almost half of women or parents of girls taking the antiepileptic had not had conversations with their medical team about its associated dangers.
In 2018, the European Medicines Agency tightened the restrictions on the use of the drug which included a pregnancy prevention programme. Following this, a HSE Valproate Response Project was commissioned which has since written a report but this remains unpublished.
HELP US INVESTIGATE
We want to investigate what is being done by the Government for mothers and children affected by valproate and why the HSE report on the issue is still unpublished. We also want to look into the recommendations of a 2018 Oireachtas report to see if they have been implemented.
We will also talk to families affected and detail the impact of not being told for decades about the risks associated with this drug.
*Note: There are health risks in switching a prescription from sodium valproate to another antiepileptic. The HSE state that such a process takes time and must be conducted by a specialist.
Have you any information that you think would help this investigation, contact us at [email protected]
If you want to know how your contribution is used, or anything else about how Noteworthy works, you can find out more here.