272 - Pregnancy: Sodium Valproate (Answered)

Paul Flynn
To ask the Secretary of State for Health, what assessment he has made of the implications for his Department's policies of recent Medicines and Healthcare Products Regulatory Agency guidelines on prescribing sodium valproate during pregnancy; and if he will implement stronger guidelines to minimise the risks of fetal valproate syndrome from use of sodium valproate.

George Freeman

The National Institute for Health and Care Excellence (NICE) is responsible for developing national clinical guidelines to secure consistent, high quality, evidence based care for patients using the National Health Service. The NICE guideline on epilepsy, The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care, makes clear that to enable informed decisions and choice, women and girls with epilepsy must be given accurate information and counselling about contraception, conception and pregnancy.

The Department worked with the Medicines and Healthcare products Regulatory Agency, healthcare professionals and patient groups to raise awareness and encourage discussion about the risks and benefits of sodium valproate between healthcare professionals and their patients. Several measures were put in place to minimize the prescribing of sodium valproate to women of childbearing potential (except where other drugs are ineffective or not tolerated) and to communicate the warnings around the drug sodium valproate to healthcare professionals and patients (particularly women of child bearing potential). These include:

- working with the Health and Social Care Information Service on introducing red-flag warnings on general practitioners and community pharmacy IT systems;

- updating the British National Formulary (BNF) and BNF for children (BNFc);

- using existing Departmental and NHS communication channels to raise awareness and provide information to patients; and

- working with the relevant Royal Colleges and professional bodies to communicate with their members and raise awareness.