Guidance
Update information
December 2023: We amended recommendations on valproate in line with Medicines and Healthcare products Regulatory Agency (MHRA) safety advice, that valproate must not be started for the first time in people (male or female) younger than 55 years, unless 2 specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.
June 2022: We updated the advice on choice of psychological intervention for bipolar depression, to link to the information in the new NICE guideline on depression in adults: treatment and management.
December 2021: Following a surveillance review we have updated recommendation 1.2.12 to say that either glycosylated haemoglobin (HbA1c) or fasting blood glucose may be used to test for diabetes, and 1.10.8 to clarify that the test is of fasting blood glucose.
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:
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moving cautions and links to the MHRA's latest advice on valproate into the recommendations
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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 to 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.
November 2017: Some recommendations were updated with current UK marketing authorisations and MHRA advice. Links to other guidelines have also been updated. Some recommendations for research have been stood down.
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. Notes have been added to the guideline to link to the MHRA's latest advice and resources.
April 2015: Recommendations related to valproate in the section on how to use medication 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
October 2024: We added links to the MHRA Drug Safety Update on valproate use in men and their partners.
July 2024: We have simplified the guideline by removing recommendations that are covered in other sources (such as other NICE guidelines or the BNF), and recommendations that are general good practice advice with no supporting evidence.
This is a presentational change only, and no changes to practice are intended.
ISBN: 978-1-4731-5658-6