Dáil Éireann Debate, Tuesday - 24 July 2018
1719. Deputy Bobby Aylward asked the Minister for Health the steps he and the Health Service Executive have taken regarding the issue of children affected by foetal anticonvulsant syndrome in circumstances in which children were exposed to sodium valproate medicines in the womb further to a meeting with members of group (details supplied); and if he will make a statement on the matter. [34474/18]
Amharc ar fhreagraThe European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) completed its review of sodium valproate in February 2018, and recommended new measures to avoid exposure of babies to valproate-containing medicines in the womb. On 31 May the European Commission issued a final legally binding decision valid across the EU.
The new measures include a ban on the use of valproate-containing medicines for migraine or bipolar disorder during pregnancy, and a ban on using such medicines to treat epilepsy during pregnancy unless there is no other effective treatment available.
In addition, these medicines must not be used in any woman or girl able to have children unless the conditions of a new pregnancy prevention programme are met. The programme is designed to ensure that patients taking valproate are fully aware of the risks and the need to avoid becoming pregnant while taking the drug.
The Health Products Regulatory Authority (HPRA) is working with national stakeholders, including patient representatives and healthcare professionals, to implement the new risk minimisation measures in Ireland, including materials developed to support safe prescribing and dispensing of valproate, and in particular to ensure that patients and carers are fully informed of the risks and can discuss options with their doctor.
Measures currently being updated in line with the new recommendations include:
- Changes to the product information for patients and healthcare professionals;
- A visual warning on the packaging of valproate medicines;
- Revised educational materials for patients and doctors; and
- A patient alert card to be attached to the product packaging
My officials and I identified a need to ensure that the response to these new recommendations formed part of an integrated plan to address current risks associated with the use of valproate in women of child-bearing age, as well as the historic issues that have been raised in relation to foetal anticonvulsant syndrome (FACS).
Accordingly my Department convened a number of meetings with the HSE and the HPRA to seek assurances on the approach being taken. The HSE has developed a Valproate Response Project Plan which sets out the agency’s approach to the issue.
The HSE is working in partnership with relevant patient representatives and clinical experts to review the diagnostic and support services required by people who may have been affected by FACS. The FACS forum is represented on both the steering group and project team. The HSE has identified several initial key dependencies to enable implementation of this plan and are working towards these.
For women currently taking sodium valproate, which is marketed under the brand name Epilim in Ireland, the clear advice from the HPRA and the HSE is that they should not stop taking this medicine suddenly; instead they should get in touch with their doctor or pharmacist for further guidance. The HSE has also updated its website with "Questions and Answers for Patients" and links to further material for healthcare professionals. This information can be accessed at www.hse.ie/valproate.
