UK media coverage outlines why outstanding valproate related commitments must be prioritised in Ireland
Last Updated: Wed, 20/04/2022 – 08:23
An in-depth feature in this week’s Sunday Times (UK) has highlighted the ongoing plight of families who have been impacted by Sodium Valproate (Epilim), their fight for redress to be provided by the British state and how even today, appropriate safety measures are not in place.
Sodium Valproate is a common epilepsy drug which if prescribed in pregnancy can have a severe impact on the foetus. In 30-40% of cases where a child has been exposed to Sodium Valproate in-utero, the child will experience a neurodevelopmental issue such as autism, ADHD or learning delays. In appox 11% of cases, a child will experience a congenital malformation such as cleft palette, limb malformations or spina bifida.
In the UK, it is estimated that up to 20,000 children could be impacted by Sodium Valproate. Following a two-year state inquiry there, it was recommended that a redress scheme should be established to support families who have been impacted, a recommendation that has yet to be implemented.
You can read this article in full by visiting the Sunday Times website or can learn more by watching the video below.
In Ireland, the HSE estimate that 1,250 children (many of whom are now adults) have been impacted by Sodium Valproate since 1975. Families want to know how this was allowed to happen despite the growing evidence over almost five decades of the drug’s teratogenicity, and why it took until 2014 and 2018 for meaningful risk reduction measures to be put in place. For this reason, Minister Stephen Donnelly announced in November 2020 that an inquiry into the historical licensing and prescribing of Sodium Valproate in Ireland would be established.
However, this has yet to happen. Over the past eight months OACS Ireland and our colleagues in Epilepsy Ireland have been in discussions with the Department of Health about the scope and terms of reference for the inquiry. We hope that following our most recent meeting in March, there will soon be an announcement with further details on the establishment of the inquiry.
Alongside the inquiry, it is vital that more is done to prevent further preventable valproate-related disabilities. Recent UK registry data showed that since 2018, almost 250 women were prescribed valproate in a month in which they were pregnant.
Unfortunately, we do not have any comparable registry in Ireland. However, findings from a survey epilepsy Ireland conducted in 2020 showed that many women with epilepsy were still dangerously unaware of the potential impacts that Sodium Valproate could have on their child if taken during pregnancy. In addition, a recent study published by the RCSI also shows that awareness of the issue and of the mandatory ‘Prevent’ pregnancy prevention programme (PPP) are variable and that the number of women taking the drug is only slowly declining. While some very positive actions were taken by the HPRA and HSE in 2018 (including dispensing the drug in its original box with package insert – something that is still an issue in the UK), it has been clear for some time that more needs to be done.
Urgency is needed from the Department, not just in terms of establishing the inquiry, but also with three other key safety measures we have been highlighting – namely,
The appointment of specialist nurses to enable greater compliance with the PPP
The establishment of a ‘stakeholder group’ to address how risks can be further reduced.
A register for children with Foetal Valproate Spectrum Disorder is of the up most urgency. You cannot deal with a issue if you do not know how many children are impacted with it.
Many families have contacted OACS Ireland in relation to issues they are having.
1.Waiting for their CHO to receive a Diagnosis/Report.
2. Waiting for ongoing engagement with Liaison Officers.
3. Waiting for their first contact with Liaison Officers
There is NO Disability Pathway in place for families harmed what is in place, is a one-page document called “the Community Appendix” which is not suitable for the harm done to our families, quite frankly it is insulting, and families deserve more.
Families are left to pick up the pieces of avoidable harm that their children are now living with. What the HSE and Department of Health must remember “if the damage is on the table, a full disability package with all needs met for the individual family unit must be on the table”.
What has occurred is an horrendous tragedy with failure to protect mothers and their vulnerable unborn babies, the same babies that have now grown up. The State needs to act now to ensure everything is in place for families impacted this is essential.
Waiting for their CHO to receive a Diagnosis/Report.
Waiting for ongoing engagement with Liaison Officers.
Waiting for their first contact with Liaison Officers
OACS Ireland welcomes that parents has had some engagement with the HSE, trying to keep that engagement going has been a problem. The HSE need to keep weekly contact with families, until families come to terms with their child and/or children’s new condition. This condition does not only relate to one child per family, it relates to multiple children in one family. OACS Ireland has continuously stated to the HSE that families need counselling, it is hard enough to have one child impacted with this condition due to a mothers intake of Epilim (Valproate) in pregnancy. To have child multiple children is a totally different thing to deal with for what a head of the individual family is. Unfortunelly, the true teratogenic effects of Epilim (Sodium Valproate) are unknown, this is due to the medication effects still evolving.
OACS Ireland and Epilepsy Ireland have lobbied for these changes for four years, but despite recent positive signals from the Department, nothing has yet come to pass. Right now, it is impossible to say that there are no children being born in Ireland in 2022 with valproate-related disabilities.
Alongside Epilepsy Ireland, we will continue to campaign on all these matters and provide further updates as they become available on our website and social media channels.
**Women and girls should not stop taking valproate without first discussing it with their doctor. For more information, OACS Ireland can be contacted at 089 219 6011 – Email: firstname.lastname@example.org website www.oacsireland.com you can also check out Epilepsy Irelands Valproate section website: https://www.epilepsy.ie/content/valproate-epilim-guidelines or call give them a call at 01 4557500. .**