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Pregnancy: Sodium Valproate

Question for Department of Health and Social Care

UIN 82046, tabled on 28 August 2020

To ask the Secretary of State for Health and Social Care, how many children have been harmed by the use of Valproate in pregnancy since 1973.

Answered on

10 September 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has been monitoring trends in the prescribing of sodium valproate in women and girls to assess the impact of regulatory restrictions including the introduction of the Pregnancy Prevention Programme (PPP) in April 2018.

Data from the NHS Business Services Authority show that in the second quarter (April-June) of 2020 13,574 women of child-bearing age (14-45 years) were dispensed with a prescription for valproate in England.

The number of pregnancies estimated to have been exposed to valproate in the United Kingdom during 2018 and 2019 were 370 and 190 respectively. These estimates are extrapolated from data from the Clinical Practice Research Datalink as national data are not collected. No data are available on the number of children harmed by valproate or the number of diagnoses with Fetal Valproate Spectrum Disorder since 2018.

The number of children harmed by the use of valproate in pregnancy since 1973 is not precisely known. However, an estimate has been made of in the region of 20,000.

The MHRA is working on developing a valproate registry, the main aims of which would be to monitor the use of valproate in girls and women in the UK and compliance with the current regulatory requirements, and to identify and monitor outcomes in any children born to women on valproate. There has been a gradual decline in prescribing of valproate to women of childbearing age over a number of years but more needs to be done to reduce prescribing to the minimum. The MHRA is working with the National Health Service and professional regulators to drive forward compliance with the PPP and ensure that women with epilepsy and bipolar disorder receive the healthcare they require.