I propose to take Questions Nos. 615 and 675 together.
The 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. These measures were subsequently endorsed by the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), a medicines regulatory body representing all EU and EEA member states. Because the CMDh position was agreed by majority vote, it was sent to the European Commission, which issued a final legally binding decision valid across the EU on 31 May.
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
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 foetal anticonvulsant syndrome (FACS).
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.
