Side Effects: Children
(asked on 10th February 2026) - View Source
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, a) what data NHS England holds regarding children who have experienced iatrogenic harm caused by anti-seizure medications (ASMs), and b) what guidance is in place to prevent this harm within NHS England.
The National Disease Registration Service (NDRS) in NHS England collects and quality assures data about people with congenital conditions and rare conditions across the whole of England. Further information on the NDRS is available at the following link:
In the most recent official statistics on congenital conditions in England, which contains information on congenital conditions detected in babies delivered in England between 1 January and 31 December 2022, and in previous publications of this series back to inception in 2018, there were no foetuses or babies reported to have a diagnosis of foetal sodium valproate syndrome. No statistics are available for congenital conditions related to other anti-seizure medications. The most recent official statistics on congenital conditions in England, the National Congenital Anomaly and Rare Disease Registration Service Congenital Condition Official Statistics Report 2022, is available at the following link:
It is likely that while some of the individual conditions, for instance neural tube defects, cardiac, oro-facial clefts, and limb difference, that can be associated with this condition are recorded on the register, the overarching diagnosis of foetal sodium valproate syndrome may not yet be registered because foetal sodium valproate syndrome may take more than a year after birth to be confirmed as a diagnosis. The NDRS is assessing the feasibility and reliability of better ascertainment of foetal sodium valproate syndrome by linking the congenital condition register to primary care prescription data.
NHS England’s Medium Term Planning Guidance requires providers to address problematic polypharmacy. Structured Medication Review (SMR) is both general concept and also a defined clinical activity in general practice. SMRs are an evidence-based and comprehensive review of a patient’s medication, taking into consideration all aspects of their health. In SMRs, clinicians and patients work as equal partners to understand the balance between the benefits and risks of, and alternatives to, taking medicines. Further information on SMRs is available at the following link:
https://www.nice.org.uk/guidance/ng5
The Medicines and Healthcare products Regulatory Agency (MHRA), continuously monitors the safety of medicines, including their use during pregnancy. MHRA updated the Summary of Product Characteristics, Patient Information Leaflets and educational materials to reflect the latest data for these medicines. The magnitude and type of risks associated with the use of antiseizure medication in pregnancy have been communicated in the MHRA Safety Roundup, Drug Safety Update, and letters through the NHS Central Alerting System. The MHRA, taking advice from the Commission on Human Medicines, has worked with professional bodies to raise awareness among healthcare professionals and patients of the risks of antiseizure medication, particularly valproate and topiramate when taken during pregnancy.