To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that clinicians are discussing with women and girls the risks of taking sodium valproate and other anti-epileptic drugs (AEDs) during pregnancy.
This answer is the replacement for a previous holding answer.
29 January 2021
The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that documents forming the basis of the valproate Pregnancy Prevention Programme are available electronically and distributed regularly as hard copies to prescribers and pharmacists to support discussions of the risks of taking sodium valproate during pregnancy with women and girls who require this medicine. Healthcare professionals have been reminded of their responsibility to inform women and girls taking valproate of the risks, through letters from the United Kingdom’s Chief Medical Officers and Chief Pharmaceutical Officers and by articles in the MHRA’s electronic bulletin Drug Safety Update. The conclusions of a safety review by the Commission of Human Medicines of the risks of other epilepsy medicines in pregnancy have recently been published to aid discussions about the most suitable treatment options.
The MHRA is working with the wider healthcare network to explore additional ways of improving the reach of regulatory communications through platforms in the healthcare and patient setting. The MHRA is working to establish a registry to monitor the use of valproate in women and girls and clinician and patient compliance with the current regulatory position.