April 2018: Footnotes and cautions in the guideline have been added and amended to link to the MHRA's latest advice and resources on sodium valproate. Medicines containing valproate taken in pregnancy can cause malformations in 11% of babies and developmental disorders in 30–40% of children after birth. Valproate treatment must not be used in girls and women including in young girls below the age of puberty, unless alternative treatments are not suitable and unless the terms of the pregnancy prevention programme are met. This programme includes: assessment of patients for the potential of becoming pregnant; pregnancy tests; counselling patients about the risks of valproate treatment; explaining the need for effective contraception throughout treatment; regular (at least annual) reviews of treatment by a specialist, and completion of a risk acknowledgement form. In pregnancy, valproate is contraindicated and an alternative treatment should be decided on, with appropriate specialist consultation. See the MHRA toolkit to ensure female patients are better informed about the risks of taking valproate during pregnancy.
Appendices A and B (details of internal/external staff and committee members) were removed as this information is now available elsewhere on the NICE website.
February 2016: The Medicines and Healthcare Products Regulatory Agency (MHRA) has produced a toolkit to ensure female patients are better informed about the risks of taking valproate during pregnancy. Healthcare professionals are advised to use the NICE guideline in conjunction with the latest MHRA advice and resources. Footnotes and cautions in the guideline have also been added and amended to link to the MHRA's latest advice and resources.
January 2015: The Medicines and Healthcare Products Regulatory Agency (MHRA) has strengthened its warnings on the use of valproate in women of childbearing potential. We are assessing the impact of this on the guideline. In the meantime, healthcare professionals are advised to use the guideline in conjunction with the latest MHRA advice.
November 2013: A footnote has been added to recommendation 126.96.36.199 highlighting new advice issued by the MHRA about oral anti-epileptic drugs (AEDs).