Pregnancy: Sodium Valproate

(asked on 14th September 2020) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to reduce the number of babies harmed by valproate in pregnancy following the failure of the pregnancy prevention program for women prescribed sodium valproate.


Answered by
Nadine Dorries Portrait
Nadine Dorries
This question was answered on 23rd September 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) is working with stakeholders to restrict the use of valproate in women of childbearing potential to those for whom other medicines are ineffective or not tolerated; to provide information to support switching of women to other antiepileptics and to improve compliance with the valproate Pregnancy Prevention Programme which aims to rapidly reduce and eventually eliminate pregnancies exposed to valproate.

It is the responsibility of every healthcare professional involved in the prescribing and dispensing of valproate to make sure women are aware of the serious risks in pregnancy and are enrolled in the statutory Pregnancy Prevention Programme. United Kingdom Chief Medical Officers wrote to all healthcare professionals in April 2018 to inform them of the actions required and in September 2018 UK Chief Pharmaceutical Officers contacted all pharmacists to remind them of their responsibilities when dispensing valproate. This has been reinforced by messages from the professional regulators to their members and by articles in the MHRA’s electronic bulletin Drug Safety Update in September and again in December 2018 calling all healthcare professionals to examine whether they are prescribing in compliance with the measures.

No data are available on the number of children harmed by valproate or the number of diagnoses with Fetal Valproate Spectrum Disorder from 2013 to 2020.

Regarding the National Compensation Fund, all recommendations of the Independent Medicines and Medical Devices Safety Review are being considered carefully. The Government will respond in due course.

Reticulating Splines