Update information
January 2025: We amended recommendations on valproate and topiramate in line with Medicines and Healthcare products Regulatory Agency (MHRA) guidance on the use of valproate, valproate use in people younger than 55 years, valproate use in men, and the use of topiramate that:
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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
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boys and men should be advised to use effective contraception (condoms, plus contraception used by a female sexual partner) throughout the valproate treatment period and for 3 months after stopping valproate
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men taking valproate who are planning a family within the next year should discuss potential fertility risks and treatment options with a healthcare professional
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topiramate should not be used in women and girls of childbearing potential unless the conditions of the Pregnancy Prevention Programme are fulfilled.
April 2022: This guideline updates and replaces NICE guideline CG137 (published January 2012).
Minor changes since publication
October 2024: We added links to the MHRA Drug Safety Update on valproate use in men and their partners.
August 2024: We added a link to NICE's guideline on adrenal insufficiency.
June 2024: We added links to the MHRA Drug Safety Update on topiramate use in pregnancy and in women and girls of childbearing potential.
December 2023: We updated information about the November 2023 MHRA safety advice on valproate to clarify that the relevant recommendations in this guideline are being reviewed.
December 2022: We added links to new MHRA safety advice on risks associated with valproate for the under 55s.
ISBN: 978-1-4731-6812-1