Clare Pelham joins expert group on sodium valproate
Epilepsy Society's chief executive Clare Pelham has joined the Sodium Valproate Expert Working Group which supports the Government's Commission on Human Medicines.
The group has been set up to ensure that women and girls of childbearing age who are prescribed the anti-epileptic drug sodium valproate, are made aware of the risks to an unborn child exposed to the drug during pregnancy.
Ten per cent of babies exposed to the drug during pregnancy are born with physical disabilities and 40 per cent are at risk of developmental issues that can lead to learning difficulties.
A recent survey carried out by Epilepsy Society in collaboration with Young Epilepsy and Epilepsy Action, showed that one in five women taking sodium valproate are not aware of the risks.
What will the group do?
The Sodium Valproate Expert Working Group has been tasked to:
- review the current risk minimisation in place (for sodium valproate) and possible reasons for lack of effectiveness.
- consider further regulatory measures required to minimise the risk of valproate use in pregnancy including, but not limited to, a contraindication for use in pregnancy in girls and women without effective contraception and a formal Pregnancy Prevention Program.
- consider other measures required across the healthcare system to ensure compliance with regulatory position in clinical practice (e.g. shared care agreements, registries.