Sodium Valproate (Epilim) and Birth Defects

Thank you for contacting me about the use of sodium valproate in epilepsy treatment.

I would like to offer my deepest sympathies to those who have been affected by birth defects or complications following the prescription of sodium valproate. Sodium valproate remains a very effective medication for epilepsy and bipolar disorder, but it should be only used in women and girls of childbearing age if all other treatments have proven ineffective.

You may be interested to know that there are very clear guidelines from the Government regarding the prescription of sodium valproate - also known as Epilim - to pregnant women who have epilepsy.

A joint NHS Improvement / MHRA Patient Safety Alert was issued in April this year and the advice can be found at www.gov.uk/drug-safety-update/valproate-and-developmental-disorders-new-alert-asking-for-patient-review-and-further-consideration-of-risk-minimisation-measures. These guidelines make it clear that sodium valproate should not be prescribed to pregnant women, and generally avoided by all women and girls of childbearing age. Only in exceptional circumstances, whereby all other medications have failed to alleviate the patient's symptoms, may sodium valproate be considered for prescription. The guidelines from the Medicines and Healthcare products Regulatory Agency (MHRA) have been widely disseminated and followed by all organisations throughout NHS England who may prescribe sodium valproate for epileptic patients from October 2017.

I understand that France has its own legislation which allows for a state-funded compensation scheme, which includes claims from those affected by sodium valproate. Whilst the Government is monitoring the system in France closely, it has no current plans to introduce an equivalent compensation fund in the UK. However, I am pleased to note that the Government has taken great steps to raise awareness amongst the healthcare profession of the risks of sodium valproate, and to commission appropriate education, health and social care needs for all children affected by foetal valproate syndrome.

You may be aware of a legal case in 2010, in which legal aid funding was withdrawn from a compensation claim made against Sanofi Aventis, the manufacturer of Epilim. I appreciate the frustration and disappointment this caused to campaigners, however this was a decision taken by the judicial system, rather than the Government. It would be inappropriate for Government ministers to comment on or intervene in matters which must remain the responsibility of the judicial system.

Thank you again for taking the time to contact me.