The use of valproate is now contraindicated in any woman or girl of childbearing potential unless they are on the Pregnancy Prevention Programme.
Valproate medicines including Epilim, Depakote and Episenta are widely used in the treatment of epilepsy and bipolar disorder. However, children born to women who use valproate during pregnancy are at a 40% risk of serious developmental disorders and 10% risk of birth defects.
Prescribers who wish to issue valproate prescriptions must make sure their female patients are enrolled in the Pregnancy Prevention Programme. This includes patients who are not sexually active, unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy.
The new regulatory measures also include an absolute contraindication for the use of valproate for bipolar disorder during pregnancy. The contraindication applies to the treatment of epilepsy in pregnancy unless there is no other effective treatment available.
GPs must identify and recall all women and girls who may be of childbearing potential, provide the patient guide and check they have been reviewed by a specialist in the last year and are on highly effective contraception.
The programme is consistent with those for other highly teratogenic drugs such as thalidomide and isotretinoin, and includes the completion of a signed risk acknowledgment form when the patient's treatment is reviewed by a specialist, at least annually.
New alerts are being set up on GP computer systems to ensure that changes in prescribing behaviour are established promptly. NHS Digital has also worked with GP system suppliers to provide a search and audit function to allow GPs to identify women and girls on valproate medicines.
NICE has reviewed its guidelines that include valproate to reflect the new regulatory position.
These changes will be supported in the upcoming months by smaller pack sizes to encourage monthly prescribing, and a warning or pictogram will be added to valproate packaging.
Previous drug safety alerts from the MHRA about the risks of valproate have had little impact on prescribing and women have reported that they still are not receiving the necessary information in a timely manner.
‘We welcome the revised measures which reflect the seriousness of the risks to the unborn children of women with epilepsy during pregnancy,’ said Simon Wigglesworth, deputy chief executive of Epilepsy Action.
‘It is vitally important that healthcare professionals ensure that all women with epilepsy taking sodium valproate are reviewed in line with the new guidelines. We are working closely with the MHRA on the implementation of these new guidelines and will be looking to see if meaningful progress will be made in avoiding life-changing harm to children born to women with epilepsy,’ he added.