Update information

Update information

Recommendations are marked as [2004], [2004, amended 2012], [2012], [new 2012] or [amended 2020].

  • [2004] indicates that the evidence has not been updated and reviewed since 2004.

  • [2004, amended 2012] indicates that the evidence has not been updated and reviewed since 2004 but a small amendment has been made to the recommendation.

  • [2012] indicates that the evidence has been reviewed but no changes have been made to the recommendation.

  • [new 2012] indicates that the evidence has been reviewed and the recommendation has been updated or added.

  • [amended 2020] indicates that a recommendation has been amended to strengthen warnings in line with the MHRA guidance on valproate use by women and girls.

February 2020: We amended recommendations 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 sodium valproate into the recommendations

  • adding bullet points to some recommendations to clarify that sodium valproate is not an option for women and girls of childbearing potential, but is an option for men, boys and women who are not of childbearing potential.

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 other treatments are unsuitable and 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.

We removed the tables from appendix E because they are no longer current.

October 2019: Because of a risk of abuse and dependence, gabapentin and pregabalin are controlled under the Misuse of Drugs Act 1971 as class C substances and scheduled under the Misuse of Drugs Regulations 2001 as schedule 3 (as of 1 April 2019). Tables have been amended and a footnote has been added to this guideline to reflect this change.

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 1.9.1.4 highlighting new advice issued by the MHRA about oral anti-epileptic drugs (AEDs).

  • National Institute for Health and Care Excellence (NICE)