Recommendations marked [amended 2020] have been amended in line with the MHRA guidance that valproate must not be used in women and girls of childbearing potential (including young girls who are likely to need treatment into their childbearing years), unless other options are unsuitable and the pregnancy prevention programme is in place
February 2020: We amended recommendations on valproate in line with the MHRA guidance on valproate use by women and girls. The MHRA states that valproate must not be used in women and girls of childbearing potential (including young girls who are likely to need treatment into their childbearing years), unless other options are unsuitable and the pregnancy prevention programme is in place. We did this by:
moving cautions and links to the MHRA's latest advice on valproate into the recommendations
adding information about valproate use to recommendations rather than relying on cross-references to other recommendations in the guideline.
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.
February 2016: The 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 have been added to the guideline to link to the MHRA's latest advice and resources.
April 2015: Recommendations 1.5.5, 1.5.8 and 1.7.6 have had links to section 1.10 added. Recommendations in section 1.10 related to valproate have been reordered, and a new recommendation on withdrawal of valproate in women of childbearing potential added. These changes are in line with the revised MHRA warning on valproate.
January 2015: The MHRA has strengthened its warnings on the use of valproate in women of childbearing potential.
Minor changes since publication
March 2020: Cross reference to NICE's guideline on supporting adult carers added to recommendation 1.1.13.
November 2017: Footnotes for some recommendations were updated with current UK marketing authorisations and Medicines and Healthcare Products Regulatory Agency (MHRA) advice. Links to other guidelines have also been updated. Some research recommendations have been stood down.