The Medicines and Healthcare products Regulatory Agency (MHRA) has updated the patient information leaflets for all valproate-containing medicines to ensure women have access to the latest information on the risk of neurodevelopmental disorders in children born to women who took the medicine during pregnancy. A pictogram warning of the risks of use in pregnancy has been added to the outer packing of valproate medicines and a patient card is available to provide more detail on actions to take.
The documents that form the basis of the valproate Pregnancy Prevention Program, including a patient guide, have been made available electronically and disseminated as hard copies to doctors and pharmacists to support discussion of the risks with women. Healthcare professionals have been reminded of their responsibility to inform women 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.
We are working with the Valproate Stakeholder Network to explore additional ways of improving the reach of regulatory communications through platforms in the healthcare and patient setting.