A 2014 Europe-wide review of valproate-containing medicines recommended strengthening of restrictions for their use and further characterising the risk of birth defects and developmental disorders in the product information.
Key Messages *
- Valproate should not be prescribed to female children, female adolescents, women of childbearing potential or pregnant women unless other treatments are ineffective or not tolerated.
- Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases).
- Valproate treatment should only be commenced and supervised by a doctor experienced in managing epilepsy and bipolar disorder in female patients.
- Before initiating treatment, the balance of the benefits of treatment with valproate must be weighed against the risks. This should be considered at routine treatment reviews, when a female reaches puberty and when a woman plans a pregnancy or becomes pregnant.
- All female patients must be informed of and understand the risks associated with valproate during pregnancy and the steps to take if pregnancy occurs or is planned.
- The valproate patient guide (below) and patient card should be provided to all female patients of child-bearing age and discussed with them to ensure full understanding of the associated risks. The prescribing doctor should also use the checklist available (below) to ensure that all necessary information has been provided to the patient and/or carer.
- All suspected adverse reactions associated with valproate-containing medicines should be reported to the HPRA via the usual methods (hpra.ie).
* taken from HPRA Drug Safety Newsletters 65 and76
- Valproate-containing medicines: Recommendation to further restrict the use of valproate in women and girls – HPRA Drug Safety Newsletter Issue 65
- Valproate-containing medicines – Additional educational materials available for healthcare professionals and patients – HPRA Drug Safety Newsletter Issue 76
- CMDh agrees to strengthen warnings on the use of valproate medicines in women and girls – European Medicines Agency
Information Resources for Medical Professionals and Patients
HSE Valproate Toolkit
The Valproate toolkit was produced by the National Clinical Programmes for Epilepsy, Mental Health and Medicines Management in consultation with the HPRA and patient groups and aims to reinforce the safety message for healthcare professionals and patients. The toolkit consists of:
Produced by the Royal College of Obstetricians and Gynaecologists in the UK, this guideline summarises the evidence on maternal and fetal outcomes in women with epilepsy.
NICE Guidelines: Epilepsies: diagnosis and management
UK guideline covers diagnosing, treating and managing epilepsy and seizures in children, young people and adults in primary and secondary care. Includes guidelines for the management of epilepsy in women and girls
SIGN (Scottish Intercollegiate Guidelines Network) guidelines (May 2015)
Guidelines on the diagnosis and management of epilepsy in adults, including revised section on epilepsy and women’s health
Epilepsy: medication options when considering pregnancy
Optiongrid decision aid to help patients and healthcare professionals talk about treating epilepsy when considering pregnancy
Epilepsy, Pregnancy & AEDs
Epilepsy Ireland leaflet with important information for women with epilepsy about epilepsy medications and pregnancy
Valproate SPCs and PILs
Download the latest versions from the HPRA website