There is a number of aspects to our ongoing campaign surrounding Sodium Valproate. We are working with our colleagues in OACS Ireland to progress these and this page outlines a summary of the issues here. What we are seeking is as follows:
- That the inquiry into the historical licensing and prescribing of Sodium Valproate announced by Minister Donnelly in November 2020 is established
- That the four currently unfilled Epilepsy Nurse Specialist posts approved in 2018 to manage the mandatory patient safety requirements for women who are prescribed Sodium Valproate are appointed
- That a stakeholder group is established by the Minister to review safety & risk measures around the prescribing and distribution of this drug
- That services are put in place to support families who have been affected
Sodium Valproate (Epilim) is a common epilepsy drug which was licensed in Ireland in 1975. However, since the 1960s, evidence was emerging that the drug could have a severe impact on the unborn child if prescribed in pregnancy. Despite this, it was not until 2014 and again in 2018 that significant measures were taken to warn women of childbearing age about the potential impacts of this drug. In the years since it was first licensed in Ireland, many women continued to be prescribed Sodium Valproate with no warnings.
For this reason, Minister for Health, Deputy Stephen Donnelly announced in Nov 2020 that an inquiry would be established into the historical licensing and prescribing of Sodium Valproate. This was a very welcome development. However, there has been little progress made since then on establishing the inquiry. Families affected by this drug have waited long enough for answers on why this was allowed to happen to them, and the promised inquiry needs to be urgently established.
With regard to the recruitment of nurses, in 2018 as part of the HSE Valproate Response Project, it was agreed that six Epilepsy Nurse Specialists would be appointed to epilepsy services in Ireland. The recruitment of the nurses would help to ensure that women currently on the drug were being informed yearly about the risks and to have discussions around family planning. This would help prevent families from being impacted by Sodium Valproate in the future. To date, only two of these nurses have been recruited.
While good work has been conducted in strengthening risk reduction measures on the use of Sodium Valproate since 2018, there is still much work left to do. The pinnacle of the risk reduction measures introduced is what is called the Pregnancy Prevention Programme. This meant that any women on Sodium Valproate had to be reviewed annually by their clinician and that they had to sign an acknowledgement every year stating they were fully aware of the risks associated with the drug.
In 2020, an Epilepsy Ireland survey found that many women who had taken or were taking the drug were dangerously unaware of the impacts Sodium Valproate could have and indeed, were equally unaware of the risk reduction measures that should be applied when on the medication. For this reason, we alongside our colleagues in OACS Ireland have called for the establishment of a stakeholder group. This would involve all involved in this issue (Department of Health, HSE, HPRA, GP & Pharmacy representatives, Patient Representatives etc) coming together to review the measures that are currently in place and to discuss where they can be strengthened – so we can ensure that no child is affected by exposure to Sodium Valproate (Epilim) in the future.
As the representative organisation of families who have been impacted by Sodium Valproate, our colleagues in OACS Ireland are leading discussions regarding the services which need to be in place for the families whose children have been impacted by Sodium Valproate. Families are caring for children (many of whom are now adults) with severe disabilities and need a pathway of services in place to support their vast and varying needs.
The below are some of the latest updates on this matter and associated articles in the news section of our website where you can read more.
- June 2022 - Sodium Valproate Inquiry Update.
- June 2022 - Sodium Valproate Inquiry Update.
- May 2022 - Irish Examiner; Minister 'committed' to inquiry into drug linked to neurological problems in 1,500 children
- May 2022 - Minister for Health Questioned on establishment of promised Sodium Valproate inquiry
- May 2022 - Outstanding Valproate Commitments raised in Dáil and media.
- April 2022 - The Journal.ie; Timeframe still not decided for inquiry into epilepsy drug that can cause birth defects
- April 2022 - UK coverage outlines why outstanding valproate related commitments must be prioritised in Ireland
- October 2021 - Sodium Valproate campaign raised during Leaders Questions in Dáil Éireann
- September 2021 - New Irish study finds that ‘continued effort is needed’ in reducing valproate risks
- August 2021 - Epilepsy Ireland & OACS Ireland urge Minister to act immediately on Sodium Valproate commitments.
- July 2021 - Sodium Valproate (Epilim) Inquiry delay raised in the Dáil
- November 2020 - Minister for Health to establish inquiry into historical licensing & use of Sodium Valproate in pregnancy
- November 2020 - Epilepsy Ireland & OACS Ireland to meet with Minister for Health regarding Sodium Valproate
- October 2020 - Epilepsy Ireland & OACS Ireland to meet with Minister for Health regarding Sodium Valproate
- September 2020 - Epilepsy Ireland & OACS Ireland seek response from Minister Donnelly regarding Independent Inquiry on Sodium Valproate
- July 2020 - Letter to Minister for Health, Stephen Donnelly regarding IMMDS UK inquiry
- July 2020 - New Government face demands for Independent Inquiry from families impacted by Sodium Valproate (Epilim) in Ireland
- July 2020 - Statement from Epilepsy Ireland on Sodium Valproate Survey Findings
- July 2020 - Survey results on the awareness of risk factors associated with Sodium Valproate (Epilim)
- July 2020 - Non-Statutory Inquiry publishes long awaited "Cumberlege Review" in the UK
- Sept 2017 - Karen Keely's presentation to the European Medicines Agency
Further information on Sodium Valproate can be found in the 'Valproate' section of our website. If you are heading about Sodium Valproate for the first time, see our section on why an inquiry was announced in November 2020. Finally, if you believe you may have been impacted by Sodium Valproate, please reach out to our colleagues in OACS Ireland.
**Women and girls should not stop taking valproate without first discussing it with their doctor. **