Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, which NHS prescription drugs contain (a) Valproate and (b) Sodium Valproate or their derivatives; and what warnings are given to patients of the associated risks to pregnant women.

The name valproate is often used to describe several medicines used in the treatment of epilepsy and bipolar disorder – sodium valproate, semisodium valproate and valproic acid.

Sodium valproate is the active constituent of the following brands of prescription drugs authorised in the United Kingdom: Epilim, Episenta, Sodium valproate Zentiva, Convulex, Sodium valproate Ivax, Valprotek, Epival, Orlept, and Sodium valproate Teva.

Valproate semisodium is the constituent of Depakote tablets and Syonell gastro resistant tablets.

All formulations of valproate (sodium valproate, valproic acid and valproate semisodium) carry a risk of birth defects if taken by pregnant women and should only be used to treat women and girls of childbearing potential if other drugs are ineffective or not tolerated. Over the years the evidence of risk has grown and following a European review on the risks of developmental disorders, which completed in 2014, there has been extensive work to communicate clear advice to health professionals and patients. Warnings about the risks of valproate if taken during pregnancy and that females of childbearing age should use an effective method of contraception throughout treatment are included in a boxed warning in the package leaflet which accompanies the medicine. This leaflet also provides detailed information of the magnitude and nature of the risk, details of the actions patients need to take, where to find additional information and the importance of discussing this with their doctor.

Warnings are present on the outer packaging of the medicine and in a patient card which should be provided by the pharmacist when valproate is dispensed. Further information on the risks is provided in a patient guide to be used to support discussions between the woman and her doctor.

A further European review, initiated because of concerns about the effectiveness of measures taken to date, will complete shortly. It will deliver a strengthened regulatory position which will enable a more structured and systematic approach, through a pregnancy prevention programme, to ensure that women understand and accept the risks of treatment, are supported in making informed choices about contraception and that there is specialist supervision and monitoring if they chose to continue with valproate treatment.